FDA Adverse Event
Malfunction
Summary report: N
SYNERGY VERSITREL
MDR report key: 4565008
·
Received March 3, 2015
Report
- Report Number
- 3004209178-2015-04030
- Event Type
- Malfunction
- Date Received
- March 3, 2015
- Date of Event
- February 8, 2015
- Report Date
- February 9, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3487A-33, LOT# V042098, IMPLANTED: 2007-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: 2003-(B)(6), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-09, LOT# LB5886, IMPLANTED: 2003-(B)(6), PRODUCT TYPE: ACCESSORY. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE STIMULATION QUIT ON THE PATIENT THE DAY PRIOR TO THE REPORT. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 147019 | SYNERGY VERSITREL | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7427V-NP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR |