FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2090887
·
Received April 26, 2011
Report
- Report Number
- 3004209178-2011-03105
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Report Date
- April 7, 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, THERE WAS A SHOCKING OR JOLTING SENSATION WHEN THE PT TURNED HER HEAD TO THE RIGHT. THE PT'S TREMOR INCREASED ON THE RIGHT HAND WHEN THE SHOCKING APPEARED. THE IMPEDANCES WERE MEASURED AND THE RESULTS WERE NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 | 47 YR | LEAD: MODEL 3387, LOT# J0437427V| LOT# NFW158421H| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| LEAD: MODEL 3387S, LOT# V061216| EXTENSION: MODEL 7482, LOT# NHU063046V| PROGRAMMER: MODEL 7438, LOT# NHL012930P| LEAD: MODEL 3387S, LOT# V061216| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU063044V |