FDA Adverse Event
Death
Summary report: N
ITREL 3
MDR report key: 1201776
·
Received October 17, 2008
Report
- Report Number
- 3004209178-2008-06651
- Event Type
- Death
- Date Received
- October 17, 2008
- Date of Event
- September 15, 2008
- Report Date
- September 22, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
A CREMATORY REPORTED A PT DEATH. THE CAUSE OF DEATH WAS UNK. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | PROGRAMMER MODEL 7434A LOT # UNK| IMPLANTED| EXPLANTED| EXTENSION MODEL 7495LZ LOT# NHK024264V| LEAD MODEL 3487A LOT#J0424928V| IMPLANTED| EXPLANTED |