FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1172106
·
Received September 18, 2008
Report
- Report Number
- 3004209178-2008-05890
- Event Type
- Malfunction
- Date Received
- September 18, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 22, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFICACY AFTER GOING THROUGH AIRPORT SECURITY. PT CONFIRMED THERE WAS AN UNSPECIFIED ISSUE WITH THE THERAPY USING THE PT PROGRAMMER. NO PT TREATMENT OR OUTCOME WAS REPORTED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFERENCE MFR REPORT #3004209178200805891.
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 | 77 YR | Required Intervention | IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| LEAD: MODEL UNK| EXPLANTED:| LEAD: MODEL UNK| LOT# NFW149773H| EXTENSION: MODEL 7482 |