FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME
MDR report key: 2760794
·
Received September 26, 2012
Report
- Report Number
- 3004209178-2012-08549
- Event Type
- Malfunction
- Date Received
- September 26, 2012
- Report Date
- August 28, 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 Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID, 399930 LOT# V007049, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER MAGNETIC RESONANCE IMAGING, PATIENT EXPERIENCED SPINAL PAIN. PATIENT HAD RECEIVED CORTISONE SHOT FROM HEALTH CARE PROFESSIONAL FOR PAIN IN SPINE. THE MRI WAS FOR SHOULDER INJURY SUSTAINED 2 MONTHS AGO WHICH INVOLVED A FALL.
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 |