FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1935935
·
Received December 3, 2010
Report
- Report Number
- 3004209178-2010-10207
- Event Type
- Malfunction
- Date Received
- December 3, 2010
- Report Date
- November 23, 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
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED NO STIMULATION SENSATION FOLLOWING EXPOSURE FROM A SECURITY GATE AT (B)(6). THE DEVICE WAS TURNED OFF DURING EXPOSURE. THE PT WS NOT ABLE TO ADJUST STIMULATION. ALL THE LIGHTS LIT UP APPROPRIATELY ON THE PT PROGRAMMER, THE UPPER LIMIT WAS REACHED. THE PT PROGRAMMER WAS WORKING AS INTENDED. ADDITIONAL INFORMATION 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 | LEAD: MODEL 3487A, LOT# J0222796V| EXPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK015236V| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT056701P| EXPLANTED:| IMPLANTED: |