FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 2041385
·
Received March 24, 2011
Report
- Report Number
- 3004209178-2011-02279
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 9, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
REC'D INFO THE PT EXPERIENCED A LOSS OF THERAPEUTIC STIMULATION WITH LEFT SIDED COVERAGE. THE DEVICE WAS REPROGRAMMED AND OBTAINED RIGHT LEG COVERAGE, BUT WHEN LEFT SIDE IS TURNED ON THERE IS EITHER NO COVERAGE AT ALL OR PT REPORTS POCKET STIMULATION. THERE IS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THIS HAS BEEN OCCURRING FOR ABOUT ONE MONTH. IMPEDANCES WERE CHECKED AND READING >4000 OHMS ON SOME BI-POLAR PAIRS. FURTHER TESTING WAS RECOMMENDED. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D A F/U REPORT WILL BE SENT.
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 | 59 YR | Male | EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-25, LOT# NAF018803N| EXTENSION: MODEL 7495-25, LOT# NAF018804N| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# L86493| PROGRAMMER: MODEL 7435, LOT# NFT072887P| EXTENSION: MODEL 7495-25, LOT# NAF018804N| EXPLANTED:| LEAD: MODEL 3998, LOT# L86493| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT072887P| IMPLANTED:| EXTENSION: MODEL 7495-25, LOT# NAF018803N| IMPLANTED:| EXPLANTED:| IMPLANTED: |