FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 2230514
·
Received August 15, 2011
Report
- Report Number
- 3004209178-2011-06328
- Event Type
- Injury
- Date Received
- August 15, 2011
- Report Date
- July 19, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION. THE NEUROSTIMULATOR AND AN EXTENSION WERE REMOVED DUE TO THE INFECTION. IT WAS NOTED THAT THE PT'S OTHER NEUROSTIMULATOR WAS REMOVED DUE TO NORMAL BATTERY DEPLETION. ADD'L INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | IMPLANTED:| EXTENSION: MODEL 7482, LOT # NHU005065V| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT # J0237005V| IMPLANTED:| EXPLANTED:| LOT # NFW114300H| IMPLANTED:| EXTENSION: MODEL 7482, LOT # NHU005064V| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT # J0237005V| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426, |