FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE STIMULATOR
MDR report key: 2880012
·
Received December 19, 2012
Report
- Report Number
- 3007566237-2012-03063
- Event Type
- Injury
- Date Received
- December 19, 2012
- Report Date
- November 28, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS A BROKEN LEAD. THE PATIENT HAD THEIR FIRST THREE IMPLANTABLE NEUROSTIMULATORS (INS) ON THE RIGHT SIDE UNTIL A LEAD WIRE BROKE. HEALTH CARE PROVIDER CAN NO LONGER PLACE DEVICE ON THE RIGHT SIDE DUE TO SCARRING.
Description of Event or Problem · 1
FOLLOW UP REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THEIR DOCTOR OR REPRESENTATIVE. IT WAS NOTED AN APPOINTMENT WAS SCHEDULED FOR (B)(6), 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTABLE STIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |