FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1913559
·
Received November 12, 2010
Report
- Report Number
- 3004209178-2010-09444
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 28, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AN INFECTION OCCURRED, AND THE PT'S PHYSICIAN INTENDED TO EXPLANT THE PT'S LEADS. THE PT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED FROM THE HCP, 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 | 7427V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU096721V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0075655N| EXPLANTED:| LOT# NAT138142H| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# J0546231V| IMPLANTABLE NEURO STIMULATOR: MODEL 7425,| LEAD: MODEL 3587A, LOT# L78895| EXTENSION: MODEL 7489, LOT# NHU096725V| EXPLANTED:| IMPLANTED: |