FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED
MDR report key: 2461558
·
Received February 20, 2012
Report
- Report Number
- 3004209178-2012-01080
- Event Type
- Injury
- Date Received
- February 20, 2012
- Report Date
- January 24, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- 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: EXTENSION MODEL 7495-51 SERIAL# (B)(4) IMPLANTED: (B)(6) 1995 EXPLANTED: (B)(6) 2012. LEAD MODEL 3487A-33 LOT# L35773 IMPLANTED: (B)(6) 1995 EXPLANTED: (B)(6) 2012. PROGRAMMER MODEL 7435 SERIAL# (B)(4).
Description of Event or Problem · 1
THE IMPEDANCE VALUES WERE LOW AND OUT OF RANGE ON 3 OUT OF 4 ELECTRODES FOLLOWING A REVISION OF THE INS. THE LEAD, EXTENSION AND ADAPTOR WERE THEN REPLACED. THE PATIENT WAS RECEIVING EXCELLENT STIMULATION AND WAS VERY PLEASED.
Description of Event or Problem · 1
THE HEALTH CARE PROVIDER CONFIRMED THAT THE LEAD HAD FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT PUERTO RICO OPERATIONS CO | 37713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR | Required Intervention |