FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1230534
·
Received November 13, 2008
Report
- Report Number
- 3004209178-2008-07408
- Event Type
- Injury
- Date Received
- November 13, 2008
- Date of Event
- September 18, 2008
- Report Date
- October 17, 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
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED RETURN OF SYMPTOMS. IT WAS DETERMINED THAT THE LEAD WAS BROKEN. THE LEAD WAS REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA.
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 | 60 YR | Required Intervention | EXPLANTED| LEAD: MODEL 3389S| EXTENSION MODEL 7482| PROGRAMMER MODEL UNKNOWN| EXPLANTED| EXPLANTED| EXTENSION MODEL 7482 |