FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 2191073
·
Received July 29, 2011
Report
- Report Number
- 3004209178-2011-05881
- Event Type
- Injury
- Date Received
- July 29, 2011
- Date of Event
- January 1, 2008
- Report Date
- July 22, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- 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 THE LEAD WAS FRACTURED, AND IT WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Required Intervention | IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| EXTENSION: MODEL 7482A, LOT# NHU168300V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LOT# NFW148267H| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A, LOT# NHU172250V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V100746| LEAD: MODEL 3387S, LOT# V099194| EXPLANTED: |