FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1823583
·
Received August 27, 2010
Report
- Report Number
- 3004209178-2010-06515
- Event Type
- Malfunction
- Date Received
- August 27, 2010
- Date of Event
- January 1, 2010
- Report Date
- July 29, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- 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
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S DEVICE WAS NOT TURNED ON WHILE GOING THROUGH A THEFT DETECTOR OR SECURITY GATE AT THE COUNTY COURTHOUSE. THE PT EXPERIENCE A LOSS OF THERAPEUTIC EFFECT FOLLOWING THIS ENVIRONMENTAL EXPOSURE. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT REC'D AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADDITIONAL INFORMATION 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 | 63 YR | EXPLANTED:| LEAD: MODEL 3387, LOT# V098699| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU207789V| IMPLANTED:| EXPLANTED: |