FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1885244
·
Received October 25, 2010
Report
- Report Number
- 3004209178-2010-08381
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFO FROM THE PT'S SPOUSE STATING THAT SINCE HAVING THE DEVICE IMPLANTED SEVERAL WEEKS AGO, THE PT HAS DEVELOPED ATRIAL FIBRILLATION AND IS CURRENTLY HOSPITALIZED. THE MANAGING PHYSICIAN TURNED THE DEVICE OFF PRIOR TO DOING A CARDIOVERSION AND TURNED IT BACK ON AFTERWARDS. THE PT DOES NOT FEEL THE DEEP BRAIN STIMULATION THERAPY IS WORKING CORRECTLY SINCE THE PROCEDURE. A REQUEST FOR A MEDTRONIC FIELD REP TO SEE THE PT WAS MADE. NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THIS REPORT. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED A F/U REPORT WILL BE SENT.
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 CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXPLANTED:| IMPLANTED: |