FDA Adverse Event
Malfunction
Summary report: N
SYNERGY VERSITREL
MDR report key: 1123863
·
Received August 15, 2008
Report
- Report Number
- 2182207-2008-04962
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- June 15, 2008
- Report Date
- July 18, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE STIMULATION BECAME INEFFECTIVE. AT FOLLOW UP, IMPEDANCES WERE TESTED AND FOUND GREATER THAN 4000 OHMS. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PT COMPLICATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY VERSITREL | LGW | MEDTRONIC NEUROMODULATION | 7427V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LEAD MODEL 3890 LOT#B0380628K| EXPLANTED| IMPLANTED |