FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 2081467
·
Received April 20, 2011
Report
- Report Number
- 3004209178-2011-02942
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 31, 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
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A LOSS OF THERAPEUTIC EFFECT. THE PT WAS IN A CAR ACCIDENT 3 MONTHS PRIOR TO THE REPORT OF SYMPTOMS. THE STIMULATION USED TO HELP THE MIDDLE OF HIS BACK DOWN TO HIS LEGS, BUT IS NOW ONLY HELPING HIS LEGS. THE PT WAS REDIRECTED TO HIS PHYSICIAN. ADDITIONAL INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7427V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT # NHU083024V| PROGRAMMER: MODEL 7435, LOT # NFT044673P| IMPLANTED:| LEAD: MODEL 3998, LOT # J0437018V| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT # NHU083062V |