FDA Adverse Event
Malfunction
Summary report: N
RESTORE
MDR report key: 3080870
·
Received April 26, 2013
Report
- Report Number
- 3004209178-2013-06961
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- January 1, 2012
- Report Date
- April 12, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377860, LOT# V001918, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 377860, LOT# V001918, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 377860, LOT# V001918. PRODUCT TYPE: LEAD: PRODUCT ID 377860, LOT# V001918. PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WIRE MOVED ABOUT A YEAR AGO. IT WAS NOTED THAT THE LEAD HAD MOVED A SECOND TIME AS WELL, BUT DATES AND SPECIFICS WERE NOT GIVEN. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183057 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR |