FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1950388
·
Received December 14, 2010
Report
- Report Number
- 3004209178-2010-10429
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Report Date
- December 2, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
SEE MFR REPORT # 3004209178-2010-10428. THE PT'S DEVICES TURN OFF WHEN SHE OPENS THE REFRIGERATOR DOOR. SHE WAS AT HOME. ADDITIONAL INFO HAS BEEN REQUESTED.
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 | LEAD: MODEL 3387S, LOT# V060436| EXTENSION: MODEL 7482A51, LOT# NHU165987V| EXTENSION: MODEL 7482A51, LOT# NHU168691V| EXPLANTED:| IMPLANTED:| IMPLANTED:| LOT# NFW145893H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| IMPLANTED:| LEAD: MODEL 3387S, LOT# V060436| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: |