FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1193439
·
Received October 7, 2008
Report
- Report Number
- 3004209178-2008-06395
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 9, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT NOTICED THAT THE DEVICE ON THE RIGHT SIDE HAD TURNED OFF AFTER EXPOSURE TO EMI UPON ENTERING PICK AND SAVE STORE. THE RIGHT SIDE DEVICE SHOWED A POR CONDITION. THE BATTERY WAS AT 3.72 AND NOT NEAR EOL. THE PATIENT REPORTED HER THERAPY HAD BEEN FINE OTHERWISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | EXPLANTED:| EXTENSION: MODEL 7495-51| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387 |