FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1884896
·
Received October 20, 2010
Report
- Report Number
- 3004209178-2010-08150
- Event Type
- Malfunction
- Date Received
- October 20, 2010
- Date of Event
- January 1, 2010
- Report Date
- September 22, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
WITH THE DEVICE SYSTEM TURNED ON, A PT HAD A LOSS OF THERAPEUTIC EFFECT. STIMULATION WAS FELT ACROSS ALL ELECTRODES ON THE PT'S RIGHT SIDE, HOWEVER NO STIMULATION WAS FELT ON THE LEFT SIDE. IT WAS NOTED THAT THERE WAS NO KNOWN ACCIDENT OR INCIDENT THAT OCCURRED, THAT COULD BE RELATED TO THE ISSUE. IMPEDANCE MEASUREMENTS WERE IN NORMAL RANGE. AN X-RAY WAS CONDUCTED ON (B)(6) 2010 AS A LEAD MIGRATION WAS SUSPECTED. THE PT'S OUTCOME WAS NOT REPORTED. ADD'L INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT 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 | 55 YR | IMPLANTED:| LEAD: MODEL 3998, LOT# J0511416V| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT045768P| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU082426V| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU052817V| IMPLANTED: |