Medtronic Kinetra 7428. Dual Program Neurostimulator for Deep Brain Stimulation. Rx only. Medtronic, Inc., 710 Medtronic
FDA device recall Z-0861-06 · posted 2006-05-27 · Terminated
Recall details
- Recalling firm
- Medtronic Neurological
- Reason for recall
- A specific subset of model 7428 Kinetra implantable neurostimulators may fail due to lifted wirebonds between the hybrid circuit and battery. This failure mechanism may present clinically as loss of functionality and a return of the patient's underlying medical conditions.
- Action taken
- An Urgent Device Recall Important Patient Management Information letter was sent to implanting and following physicians of patients who have received the device. The letter describes the issue and provides recommendations.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHY
- Quantity affected
- 24
- Distribution
- USA--States of CA, OR, PA. Internationally -Belgium, France, Germany, Italy, Spain, Switzerland, United Kingdom
- Date initiated
- 2006-04-04
- Date posted
- 2006-05-27
- Date terminated
- 2006-12-26
- Location
- Minneapolis, MN
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