FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2030925
·
Received March 4, 2011
Report
- Report Number
- 3004209178-2011-01665
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Report Date
- March 1, 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 THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) CONTINUED TO SHUT OFF. IT WAS UNCLEAR IF THIS WAS DUE TO EMI. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT #3004209178201101664.
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 | EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LOT# NFW159889H| EXTENSION: MODEL 7482A51, LOT# NHU199544V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V285122| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU199545V| EXPLANTED:| LEAD: MODEL 3387S, LOT# V298925| IMPLANTABLE NEURO STIMULATOR: MODEL 7426 |