FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1944307
·
Received December 6, 2010
Report
- Report Number
- 3004209178-2010-10240
- Event Type
- Malfunction
- Date Received
- December 6, 2010
- Report Date
- November 24, 2010
- Manufacturer
- MDT 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 PT EXPERIENCED A SHOCKING/JOLTING SENSATION AT THE LEAD-EXTENSION CONNECTION SITE SINCE A CAR ACCIDENT. THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 4,000 OHMS ON SOME OF THE BIPOLAR PAIRS. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU057090V| PROGRAMMER: MODEL 7435, LOT# NFT040607P| UNK CONVERSION TYPE: MODEL 3550-09, LOT# LC0284| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3587A, LOT# LC2090 |