Recall Z-2784-2015
St Jude Medical Cardiac Rhythm Management Division · initiated August 18, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
Codes / lots: Model: EX1150 Serial #: 02902036 05103228 12200027 12200047 12200063 12200065 12200071 12200093 12200100 12200111 12200120 12200122 12200157 12200165 12200168 12200174 12200187 12200235 12200245 12200250 12200331 12200333 12200351 12200367 12200369 12200371 12200399 12200432 12200449 12200459 12200466 12200471 12200478 12200522 12200539 12200574 12200582 12200621 12200641 12200658 12200661 12200679 12200680 12200700 12200738 12200749 12200754 12200758 12200771 12200772 12200788 12200791 12200800 12200832 12200845 12200850 12200851 12200864 12200868 12200877 12200891 12200892 12200906 12200914 12200945 12200963 12200965 12200966 12200967 12200972 12200975 12200976 12200977 12200978 12200980 12200987 12200991 12200992 12200997 12200999 12201000 12201001 12201002 12201005 12201006 12201007 12201008 12201010 12201011 12201016 12201019 12201020 12201025 12201026 12201036 12201037 12201038 12201039 12201040 12201042 12201043 12201048 12201054 12201055 12201056 12201060 12201064 12201066 12201067 12201068 12201071 12201073 12201074 12201096 12201116 12201117 12201122 12201128 12201132 12201178 12201190 12201194 12201204 12201213 12201230 12201231 12201244 12201247 12201249 12201252…
Reason for recall
Some devices exhibit backup VVI operation due to a backup reset.
FDA-determined cause: Software change control
Action taken
The notification material is in the form of a Physician Letter was delivered to physicians by FedEx overnight service. The mailing went out on August 17, 2015 for receipt on August 18, 2015. The firm's notification letter identifies clinical implications. Clinical Implications In the event that an Ellipse, Fortify Assura, Unify Assura, or Quadra Assura ICD enters the back-up safety mode, the nominal operational settings will be VVI pacing mode, 67 ppm, 5.0v/0.6ms with bipolar pacing output and defibrillation settings of aVF detection rate of 146 bpm and 36J high voltage therapy. In the event an Assurity or Allure pacemaker enters backup mode, it will have output settings of VVI pacing mode, 67 ppm, 5.0v/0.6ms with unipolar pacing. This anomaly can only occur when the patient is being actively monitored by a Merlin@home bedside transmitter. If a device enters backup mode, the ICD will deliver a patient vibratory alert and the pacemaker will deliver a patient audible alert. If backup operation is encountered, St. Jude Medical Technical Services (1-800-722-3774) can assist with non-invasively restoring the device to normal operation. The firm's notification also idenfities recommendations and mitigations. Recommendations and Mitigations Once available, a Merlin@home transmitter software update will be performed automatically over its telephone, broadband or cellular connection without requiring any action from you or your patients. No changes to the patients remote or in-clinic follow up schedules are required. In the event a patients device reverts to back-up mode, the firm recommends bringing the patient back in the clinic to clear the condition and return the device to full functionality. If you have any questions or concerns contact the local St. Jude Medical representative or St. Jude Medical's Technical Services Department.
Details
- Recall number
- Z-2784-2015
- Initiated
- August 18, 2015
- Posted by FDA
- September 28, 2015
- Terminated
- May 19, 2016
- Product code
- NVZ – Pulse Generator, Permanent, Implantable
- Quantity
- 259,214 transmitters (U.S. distribution) 23,604 (foreign distribution)
- Distribution
- Worldwide Distribution-US (nationwide) and foreign distribution to the following: Japan, France, Austria, Canada, Italy, Spain, Netherlands, South Africa, Great Britain, Australia, Sweden, Belgium, Finland, Germany, Portugal, Singapore, Norway, Poland, Ireland, Czech Republic. Denmark, Hong Kong, Saudi Arabia, Hungary, Switzerland.
- Recalling firm
- St Jude Medical Cardiac Rhythm Management Division, Sylmar, CA