FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 1910621
·
Received November 19, 2010
Report
- Report Number
- 3004209178-2010-09815
- Event Type
- Injury
- Date Received
- November 19, 2010
- Date of Event
- January 1, 2010
- Report Date
- November 12, 2010
- 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
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD PREVIOUSLY GOTTEN THE DEVICE "CAUGHT IN CHAIR" AND HAD SURGERY TO FIX IT ALTHOUGH THE DEVICE WAS NOT REPLACED AT THAT TIME. FOLLOWING THE SURGERY, THE PT REPORTED SHE NOW HAS "A SHORT" IN HER DEVICE. THE PT DID STATE THE PAIN MGMT DOCTOR WAS GOING TO TRY CHANGING BATTERY TO SEE IF THAT WOULD HELP. NO SYMPTOMS OR ADDITIONAL INFO WERE REPORTED REGARDING EITHER EVENT. ADDITIONAL INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL 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 | 53 YR | Required Intervention | EXTENSION: MODEL 7489, LOT# NHU009396V| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT028426P| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU016126V| IMPLANTED:| LEAD: MODEL 3998, LOT# LB4599A| IMPLANTED: |