FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 2101916
·
Received May 18, 2011
Report
- Report Number
- 3004209178-2011-03631
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Report Date
- April 18, 2011
- 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
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT SUDDENLY LOST THERAPEUTIC EFFECT AND STIMULATION SENSATION. THERE WAS NO KNOWN ACCIDENT OR INCIDENT. THE PT PROGRAMMER CONFIRMED THAT THE DEVICE WAS ON, BUT WHEN INTENSITY WAS INCREASED, THERE WAS NO STIMULATION FELT. ADDITIONAL INFO WAS 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 | PROGRAMMER: MODEL 7435, LOT# NFT060463P| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-66, LOT# XS0005822N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3887, LOT# J0008046V| EXTENSION: MODEL 7495-66, LOT# *UK6090306| LEAD: MODEL 3887, LOT# J0008046V| IMPLANTED: |