FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1180998
·
Received September 29, 2008
Report
- Report Number
- 3004209178-2008-06178
- Event Type
- Malfunction
- Date Received
- September 29, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 27, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS GETTING GOOD COVERAGE ON THE LEFT SIDE, HOWEVER WHEN HE TURNED ON THE SECOND LEAD HE EXPERIENCED A SHOCKING OR JOLTING SENSATION. IMPEDANCE READINGS ON ALL OR SOME OF THE UNIPOLAR PAIRS WERE>4000 OHMS. NO OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998| EXTENSION: MODEL 7489| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489| IMPLANTED: |