FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1913498
·
Received November 12, 2010
Report
- Report Number
- 3004209178-2010-09439
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Report Date
- October 28, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT DID NOT FEEL WELL. THE PT'S INS WAS NOTED TO BE OFF AND WAS, THEN, TURNED ON USING THE PT PROGRAMMER. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED, BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | UNK | IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU173128V| EXPLANTED:| LEAD: MODEL 3387S, LOT# UNK| IMPLANTED:| LEAD: MODEL 3387S, LOT# UNK| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU178567V| EXPLANTED: |