FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1890218
·
Received October 22, 2010
Report
- Report Number
- 3004209178-2010-08292
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 25, 2010
- Report Date
- September 27, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- 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 IMPLANTABLE PULSE GENERATOR SHUT OFF AFTER A REPROGRAMMING OR ADJUSTMENT. THE DR REPROGRAMMED THE DEVICE SEVERAL TIMES AND WAS FINALLY ABLE TO FUNCTION NORMALLY. IT WAS ALSO NOTED THAT THERE WERE NO STRONG MAGNETIC FIELDS NEARBY AND THE BATTERY CAPACITY WAS OK. PT'S STATUS WAS UNAVAILABLE AT THE TIME OF THIS REPORT. ADD'L INFO HAS BEEN REQUESTED AND WILL BE MADE AS F/U AS IT 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 | EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389, LOT# B0708987K| EXTENSION: MODEL 7482, LOT# NHU140211V| IMPLANTED: |