FDA Adverse Event
Malfunction
Summary report: N
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
MDR report key: 6066781
·
Received October 31, 2016
Report
- Report Number
- 3007566237-2016-03813
- Event Type
- Malfunction
- Date Received
- October 31, 2016
- Date of Event
- January 1, 2010
- Report Date
- October 31, 2016
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS IMPLANTED IN 2010 AND STOPPED WORKING IN 2010. THE HCP DID NOT HAVE ANY OTHER DETAILS ABOUT WHY THE STIMULATOR STOPPED WORKING. NO SYMPTOMS WERE REPORTED. THE PATIENT WAS TO HAVE AN MRI SCAN OF THE KNEE. IT WAS NOTED THAT THE PATIENT DID NOT HAVE A MANAGING HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 718125 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |