FDA Adverse Event
Death
Summary report: N
SOLETRA
MDR report key: 1050227
·
Received May 22, 2008
Report
- Report Number
- 3004209178-2008-02747
- Event Type
- Death
- Date Received
- May 22, 2008
- Date of Event
- April 8, 2008
- Report Date
- May 22, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT DIED. THE CAUSE OF DEATH WAS UNK. ADD'L INFO REC'D FROM THE HCP STATED, THEY WERE UNAWARE THE PT HAD EXPIRED. THE PT HAD BEEN TREATED FOR ESSENTIAL TREMORS. THE PT WAS SEEN LAST BY THE HCP IN 2007 FOR A BATTERY CHANGE.
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 | 91 YR | Death | EXTENSION MODEL 7495-51 LOT# XR0006124V| IMPLANTED| IMPLANTED| EXPLANTED| LEAD MODEL 3387 LOT# J0118386V| EXPLANTED |