Recall Z-0593-2019
St. Jude Medical, Inc. · initiated October 11, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 6172 STERILE EO Rx ONLY St. Jude Medical Plano, TX Instructions For Use: Lead and Extension Kits for Deep Brain Stimulation Systems Clinician's Manual ST. JUDE MEDICAL - Product Usage: St. Jude Medical Deep Brain Stimulation (DBS)leads are intended to deliver stimulation to target areas in the brain. DBS extensions are intended to connect the leads to implantable pulse generators (IPGs). St. Jude Medical DBS leads are designed for introduction into the brain using standard stereotactic neurosurgical techniques. DBS system delivers electrical stimulation to a precisely targeted area in the brain. Leads are implanted in the brain and are connected to extensions, which are passed under the skin and are connected to the neurostimulator. Leads for the St. Jude Medical Infinity DBS System feature electrodes on a stiff distal end with an inactive lead tip. The proximal end of the lead contains contact bands that correspond with each of the distal electrodes and an inactive band that functions as a contact for a setscrew when connecting to a compatible extension. The 8-channel leads contain cylindrical and segmented electrodes. The segmented electrodes can be activated independently to focus stimulation in one direction to help target desired neurological structures. As stated in Clinician manual (ARTEN600008305 Rev A), leads materials which are intended to come into contact with tissue are Platinum-iridium and polycarbonate urethane. In addition, drawing for the Stim Tip, 1-3-3-1 Directional DBS lead requires that the electrode material shall be 90/10 Platinum Iridium.
Codes / lots: For Model 6170ANS: UDI/GTIN - 05415067020635 / 05415067030306 US: Serial Numbers Lot Number 17277045 6351121 OUS: 17145460 6244627 17149644 6262443 17149652 6262443 17149625 6262443 17149630 6262443 17149631 6262443 17149647 6262443 17149650 6262443 17149653 6262443 17168532 6272675 17168533 6272675 17168534 6272675 17168541 6272675 17145439 6244627 17145459 6244627 17145461 6244627 17145463 6244627 17113441 6212647 17113442 6212647 17113445 6212647 17145451 6244627 17113436 6212647 17145454 6244627 17145458 6244627 17145438 6244627 17145446 6244627 17145448 6244627 17145453 6244627 17145457 6244627 17145462 6244627 17166635 6272679 17113438 6212647 17149635 6262443 17149641 6262443 17149655 6262443 17166627 6272679 17149629 6262443 17149633 6262443 17149637 6262443 17149645 6262443 17149646 6262443 17149626 6262443 17149654 6262443 17145447 6244627 17145456 6244627 17215431 6299732 17215434 6299732 17215455 6299732 17113440 6212647 17113447 6212647 17149624 6262443 17149640 6262443 17166633 6272679 17149634 6262443 17215427 6299732 17215438 6299732 17215440 6299732 17215444 6299732 17145441 6244627 17145444 6244627 17149628 6262443 17149649 6262443 17166624 6272679 17166631…
Reason for recall
The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.
FDA-determined cause: Mixed-up of materials/components
Action taken
On October 11, 2018, the firm sent an Urgent Medical Device Recall Notice to customers (i.e, Hospital Administrators) via overnight mail service informing them that the firm's records indicate that the institution has/had received the affected 8-Channel Lead that may be impacted by an isolated manufacturing issue. The notification explains that the firm believes that some of the listed leads may contain an electrode that does not conform to material specification. In total, there have been four (4) reports from (2) centers describing that the most proximal stimulation tip electrode (electrode position 4) appeared lighter than the more distal electrodes when radiographed. There have been no reports of patient harm to date. Further communication with additional details about this action, inclusive of management recommendations for any patients that may have been implanted with an affected lead, will be forthcoming as soon as possible. The notification also informs the customer that the firm's representative will assist with removing these leads from the customer's account and will facilitate replacing them. The firm is requesting the customer's support on the removal and return of these leads. The FDA has been notified of this activity. In the meantime, if hospitals or it's physicians have any questions, they can contact their local Sales Representative or Abbott Support at 1-800-727-7846 (Opt3). Customers were also provided with an Acknowledgement Form and instructed to complete all requested information and to return immediately. The Acknowledgement Form included a list of the models and serial numbers of the devices that have been delivered to the facilities, but that records do not yet reflect an implant. The customer is instructed to review and indicate if the device(s) were removed or implanted. Customer are instructed to please return the Acknowledgement Form to Abbott at email: DBSNotices@Abbott.com. On October 29, 2018, the firm sending out
Details
- Recall number
- Z-0593-2019
- Initiated
- October 11, 2018
- Terminated
- September 13, 2022
- Product code
- MHY – Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Distribution
- Worldwide distribution - US nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, MD, MN, MO, MT, NC, NJ, NY, OH, PA, and WA. International distribution in the countries of Argentina, Australia, Austria, Belgium, Brazil, Colombia, Czech Republic, Finland, France, Germany, Hungary, Italy, Mexico, Poland, Russian Federation, Saudi Arabia, South Korea, Spain, Sweden, Taiwan, Turkey, and…
- Recalling firm
- St. Jude Medical, Inc., Plano, TX