FDA Adverse Event
Malfunction
Summary report: N
NEUROSTIMULATOR
MDR report key: 2548751
·
Received April 25, 2012
Report
- Report Number
- 3007566237-2012-00900
- Event Type
- Malfunction
- Date Received
- April 25, 2012
- Date of Event
- March 27, 2012
- Report Date
- March 28, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF THE LEAD MODEL 3389S-40, LOT V780329 FOUND NO ANOMALY. CONTINUITY WAS ACCEPTABLE. ANALYSIS OF THE EXTENSION MODEL 7482-51 SERIAL (B)(4) FOUND THE DISTAL END CONNECTED WAS TWISTED IN THE MOLDED RUBBER FROM OVERSTRESS. THE #0 CONDUCTOR WAS BROKEN 0.7 CM FROM THE DISTAL END. THE #0 CIRCUIT WAS OPEN.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGERY THE PATIENT WAS IMPLANTED WITH A 3389S LEAD, BUT EVEN WHEN VOLTAGE WAS INCREASED TO 7.0-8.0 VOLTS THE PATIENT DID NOT RECEIVE ANY THERAPEUTIC BENEFIT. THE DOCTOR CHANGED THE OTHER 3389S LEAD WITHOUT IMPROVEMENT. THE DOCTOR THEN CHANGED A 3389 LEAD AND THE PATIENT COULD FEEL THE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |