FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 1130443
·
Received August 8, 2008
Report
- Report Number
- 6000032-2008-04834
- Event Type
- Injury
- Date Received
- August 8, 2008
- Date of Event
- April 1, 2008
- Report Date
- July 10, 2008
- Manufacturer
- MDT PUERTO RICO OEPRATIONS CO, MED REL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE HCP REPORTED THAT THE LEAD WAS TESTED AND FOUND TO HAVE HIGH IMPEDANCES. THE LEAD WAS REPLACED. THE PATIENT EXPERIENCED NEW PAIN AS A RESULT ASSOCIATED WITH THE EVENT. THE HCP REPORTED THE PATIENT OUTCOME AS 'RECOVERED WITHOUT SEQUELA'.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OEPRATIONS CO, MED REL | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| EXPLANTED:| LEAD MODEL 3487A LOT# N22008K| LOT# NAT104232H| LEAD MODEL 3487A LOT# J0211576V| IMPLANTED:| EXTENSION MODEL 7495-51 LOT# XR0032173N| EXTENSION MODEL 7495LZ LOT# NHK009576V| PROGRAMMER MODEL 7435 LOT# NFT018690P| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL 7425| PROGRAMMER MODEL 7434 LOT# YN0019888P| EXPLANTED:| EXPLANTED:| IMPLANTED: |