FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 2802020
·
Received October 23, 2012
Report
- Report Number
- 3007566237-2012-02498
- Event Type
- Injury
- Date Received
- October 23, 2012
- Report Date
- September 25, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3389-28, LOT# UNKNOWN, EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4).
Additional Manufacturer Narrative · 1
ANALYSIS OF THE LEAD FOUND BROKEN CONDUCTOR, UNKNOWN ANCHOR SITE. ALL CONDUCTORS WERE BROKEN 8 CM FROM THE DISTAL END.
Description of Event or Problem · 1
IT WAS REPORTED IMPEDANCES FOUND TO HAVE BEEN HIGH, 6,000 OHMS, AND ABOVE. ALL VALUES WERE OUT OF RANGE. AN X-RAY AND CT SCAN FOUND NO ISSUES. THE PATIENT UNDERWENT SURGERY AND IT WAS DETERMINED ONE OF THE LEADS WAS THE PROBLEM. THE LEAD WAS EXPLANTED AND REPLACED, AND IMPEDANCE WAS NORMAL. THERE WAS NO VISIBLE FRACTURE OR BREAK IN THE LEAD. IT WAS NOTED THE PATIENT HAD A LOSS OF THERAPY AND RETURNED SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |