FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1823536
·
Received August 27, 2010
Report
- Report Number
- 3004209178-2010-06506
- Event Type
- Malfunction
- Date Received
- August 27, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 30, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- 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 EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, IMPEDANCE MEASUREMENTS WERE NOTED AS NORMAL ALTHOUGH SOME WERE "A LITTLE HIGHER" THAN NORMAL. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | PROGRAMMER: MODEL 7435, LOT# NFT048264P| EXPLANTED:| UNK CONVERSION TYPE: MODEL 3550-09, LOT # N0019230| EXTENSION: MODEL 7489, LOT# NHU073777V| LEAD: MODEL 3487A, LOT# J0455300V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED: |