FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3003941
·
Received March 14, 2013
Report
- Report Number
- 3007566237-2013-00778
- Event Type
- Malfunction
- Date Received
- March 14, 2013
- Report Date
- February 21, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED HIGH IMPEDANCES, GREATER THAN 10,000 OHMS, WERE MEASURED ON THE DEVICE. IT WAS ALSO REPORTED THE HEALTHCARE PROVIDER WANTED TO SEND THE DEVICE BACK TO THE MANUFACTURER FOR ANALYSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107739 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |