FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME
MDR report key: 2852582
·
Received November 30, 2012
Report
- Report Number
- 3004209178-2012-10974
- Event Type
- Injury
- Date Received
- November 30, 2012
- Report Date
- November 2, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 355031 LOT# N204029, IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE SCREENING DEVICE. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT HAD A REVISION WITH THE IMPLANTABLE NEUROSTIMULATOR AND LEADS DUE TO THERAPY COVERAGE ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT PUERTO RICO OPERATIONS CO | 37701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Required Intervention |