FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 2161113
·
Received June 17, 2011
Report
- Report Number
- 3007566237-2011-04555
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 19, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT FELL AND ONE OF HER LEADS STOPPED WORKING. THE IMPEDANCES WERE MEASURED AND WERE OUT OF RANGE. THE PATIENT WAS GETTING GOOD THERAPY FROM THE LEAD THAT WORKED. A REVISION WAS PLANNED FOR JULY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MEDTRONIC NEUROMODULATION | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| IMPLANTED:| UNKNOWN CONVERSION TYPE: MODEL LEADN, LOT# UNK |