Recall Z-0694-2008

Medtronic Neuromodulation · initiated October 1, 2007

Terminated

Product

Medtronic Soletra 7426, Quadripolar Multi-Programmable Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA (The Medtronic Activa System in an implantable, multiprogrammable quadripolar system that delivers electrical stimulation to selected areas of the brain)

Codes / lots: NFW109187H, NFW109204H, NFW109214H, NFW109227H, NFW109228H, NFW109230H, NFW109249H, NFW109257H, NFW109268H, NFW109270H, NFW109271H, NFW109276H, NFW109289H, NFW109331H, NFW109333H, NFW109334H, NFW109338H, NFW109345H, NFW109368H, NFW109380H, NFW109384H, NFW109390H, NFW109393H, NFW109401H, NFW109404H, NFW109425H, NFW109426H, NFW109431H, NFW109432H, NFW109435H, NFW109437H, NFW109440H, NFW109442H, NFW109454H, NFW109459H, NFW109461H, NFW109482H, NFW109485H, NFW109487H, NFW109489H, NFW109501H, NFW109502H, NFW109503H, NFW109504H, NFW109505H, NFW109511H, NFW109513H, NFW109515H, NFW109528H, NFW109529H, NFW109532H, NFW109535H, NFW109540H, NFW109542H, NFW109545H, NFW109556H, NFW109557H, NFW109558H, NFW109562H, NFW109571H, NFW109575H, NFW109580H, NFW109581H, NFW109582H, NFW109584H, NFW109586H, NFW109597H, NFW109605H, NFW109610H, NFW109613H, NFW109618H, NFW109626H, NFW109627H, NFW109628H, NFW109632H, NFW109633H, NFW109640H, NFW109641H, NFW109644H, NFW109646H, NFW109647H, NFW109650H, NFW109653H, NFW109654H, NFW109657H, NFW109660H, NFW109663H, NFW109669H, NFW109673H, NFW109679H, NFW109681H, NFW109682H, NFW109683H, NFW109685H, NFW109690H, NFW109711H, NFW109715H, NFW109719H, NFW109727H…

Reason for recall

Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.

FDA-determined cause: Packaging change control

Action taken

A letter "Medtronic Urgent: Device Recall" dated October 2007 was sent to Healthcare Professionals. The letter described the device defect, product involved, root cause, probability of occurrence, recommendations and also provided information for assistance. At the time of the recall all of the product remaining in date for use (not expired) had been implanted, therefore Medtronic provided Important Patient Management Information for the implanting physicians to use in patient care and decisions regarding patient explants.

Details

Recall number
Z-0694-2008
Initiated
October 1, 2007
Posted by FDA
February 5, 2008
Terminated
May 3, 2012
Product code
MHY – Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Quantity
1,652
Distribution
Worldwide: USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, WA, WI, WY, UT, VA, VT, and WV and countries of Australia , Austria , Belgium , Canada , Cyprus , Czech Republic , Denmark , Finland , France , Germany , Greece , Hong Kong , Hungary…
Recalling firm
Medtronic Neuromodulation, Minneapolis, MN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0693-2008 Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx…Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit… 10/01/2007Terminated