FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1101838
·
Received August 7, 2008
Report
- Report Number
- 3004209178-2008-04773
- Event Type
- Injury
- Date Received
- August 7, 2008
- Date of Event
- July 2, 2008
- Report Date
- July 11, 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
- DC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS FOR COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD THE DEVICE REPLACED. THE HCP WAS CONCERNED ABOUT THE DEVICE LONGEVITY. NO PARAMETER HISTORY WAS REPORTED. NO SYMPTOMS OR OUTCOME WERE REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO 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 | 57 YR | Required Intervention | EXPLANTED:| IMPLANTED:| EXTENSION MODEL 7482 LOT# NHU109645V| PROGRAMMER MODEL 7438 LOT# NHL015963P| EXPLANTED:| IMPLANTED:| LEAD MODEL 3387 LOT# V000625 |