FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3160179
·
Received June 10, 2013
Report
- Report Number
- 3007566237-2013-01916
- Event Type
- Injury
- Date Received
- June 10, 2013
- Report Date
- May 20, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S DEVICE LASTED ¿ONLY 18 MONTHS.¿ IT WAS INDICATED THAT THE DEVICE WAS REPLACED. IT WAS NOTED THAT THE PATIENT WAS (B)(6) AND OTHER THAN PAIN MANAGEMENT, SHE WAS FINE BUT THE REPORTER STATED THAT THE SURGERIES FOR ¿SHORT-LIVED BATTERIES¿ THREATENED HER LIFE AT HER AGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260385 | IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |