FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2251122
·
Received September 8, 2011
Report
- Report Number
- 3004209178-2011-07532
- Event Type
- Malfunction
- Date Received
- September 8, 2011
- Date of Event
- August 1, 2011
- Report Date
- August 19, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT COULD NOT ADJUST STIMULATION. IT WAS REPORTED THAT THE DEVICES WERE TURNED OFF AND THE PT WAS UNABLE TO TURN THEM BACK ON USING THE PT PROGRAMMER. LATER IT WAS REPORTED THAT THE DEFIBRILLATOR HAD SHUT OFF SEVERAL TIMES LATELY AND THE PT STILL HAD CONCERNS WITH THEIR DEVICE. THE PT HAD AN APPOINTMENT WITH THEIR HEALTHCARE PROVIDER. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MFR REPORT# 3004209178-2011-07533.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | IMPLANTED:| LEAD: MODEL 3387S, LOT# V635198| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL030612P| EXPLANTED,| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU223713V| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU225111V| LEAD: MODEL 3387S-40, LOT# V635198| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| LOT# NFW169322H| IMPLANTED:| IMPLANTED: |