FDA Adverse Event
Injury
Summary report: N
RESTORE
MDR report key: 3869112
·
Received June 12, 2014
Report
- Report Number
- 3004209178-2014-11462
- Event Type
- Injury
- Date Received
- June 12, 2014
- Report Date
- May 22, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- 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
CONCOMITANT PRODUCTS: PRODUCT ID 377860, LOT # V010409, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377860, LOT # V010409, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748925, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748925, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT¿S DEVICE HAD ¿GONE WACKO.¿ IT WAS NOTED THE STIMULATOR WAS REPLACED DUE TO BEING DEAD AND NOT TAKING A CHARGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347180 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | Required Intervention |