FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1231233
·
Received November 13, 2008
Report
- Report Number
- 3004209178-2008-07420
- Event Type
- Malfunction
- Date Received
- November 13, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 13, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE STIMULATOR DID NOT WORK FOR THE PT ANYMORE. THE PT EXPERIENCED PAIN WHERE THE STIMULATOR SITE POSITIONALLY. THE DEVICE WILL BE EXPLANTED FOR THIS REASON. IT WAS ALSO REPORTED THE PT NEEDS A MRI SCAN. THE HCP HAD INFORMED THE PT, THE WIRES MAY OR MAY NOT BE ABLE TO COME OUT. THE PT WAS REDIRECTED TO CONTACT THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7427V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | IMPLANTED:| IMPLANTED:| LEAD: MODEL 3998| EXPLANTED:| PROGRAMMERL: MODEL 7435| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489| EXTENSION: MODEL 7489| IMPLANTED: |