FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1915536
·
Received November 5, 2010
Report
- Report Number
- 3004209178-2010-08974
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 16, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
SEE ALSO MANUFACTURER REPORT # 6000032-2010-08976. IT WAS REPORTED THAT WHILE THE STIMULATION WAS TURNED ON, THE PT STATED THAT ONE OF THE WIRES WAS "SHORTING OUT." NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF INFO BECOMES AVAILABLE.
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 | 51 YR | IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT006354P| EXTENSION: MODEL 7495-51, LOT# XR0063737N| EXPLANTED:| EXTENSION: MODEL 7495-66, LOT# XS0005956N| EXPLANTED:| LEAD: MODEL 3998, LOT# L83338| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3587A, LOT# L61186A| EXPLANTED:| PROGRAMMER: MODEL 7434, LOT# YN0032422P| EXPLANTED:| LOT# NAT114014H| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7425| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-66, LOT# XS0005198N| IMPLANTED:| EXPLANTED: |