FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3222431
·
Received July 12, 2013
Report
- Report Number
- 3007566237-2013-02323
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- June 25, 2013
- Report Date
- June 25, 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
PRODUCT ID 3877-45, LOT# 0204546198, IMPLANTED: 2012-(B)(6), (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT LOW IMPEDANCE OCCURRED AND "PERHAPS DISCHARGED ANOMALY THE RESTORE SENSOR." IT WAS STATED THAT "PLOT" 1 AND 2 HAD LESS THAN 50 OHMS. IT WAS LATER REPORTED THAT AN X-RAY WAS PERFORMED AND SHOWED NO LEAD MOVEMENT. IT WAS INDICATED THAT A NEW PROGRAMING WAS PERFORMED AND THE PATIENT WAS DOING "OK" WITH NO PROBLEM OF CHARGING. THE DEVICE WOULD NOT BE RETURNED. IT WAS NOT CLEAR IF THE LEAD AND IMPLANTABLE NEUROSTIMULATOR WOULD REMAIN IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322764 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |