FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED
MDR report key: 2576708
·
Received May 16, 2012
Report
- Report Number
- 3004209178-2012-03362
- Event Type
- Malfunction
- Date Received
- May 16, 2012
- Report Date
- April 17, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: LEAD: MODEL 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA. LEAD: MODEL 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA. RECHARGER: MODEL 37752, SERIAL# (B)(4). PROGRAMMER: MODEL 37743, SERIAL# (B)(4). ANCHOR: MODEL 3550-39, LOT# N251848, IMPLANTED: (B)(6) 2010, EXPLANTED: NA. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING/JOLTING. DETAILS REGARDING THE EVENT WERE NOT AVAILABLE, ONLY THAT IT WAS A ONE-TIME OCCURRENCE. THE PATIENT'S THERAPY WAS NOTED TO BE "FINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |