FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 1980279
·
Received February 2, 2011
Report
- Report Number
- 3004209178-2011-00808
- Event Type
- Injury
- Date Received
- February 2, 2011
- Date of Event
- September 1, 2010
- Report Date
- January 19, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD THEIR NEUROSTIMULATOR AND EXTENSION EXPLANTED DUE TO INFECTION. PT'S OUTCOME WAS NOTED AS NON-SERIOUS INJURY/ILLNESS.
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 | 71 YR | Required Intervention | EXPLANTED:| EXTENSION: MODEL 7495-51, LOT # XR0071324N| EXTENSION: MODEL 7495-51, LOT # XR0071321N| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT # L75274| EXPLANTED:| IMPLANTED: |