FDA Adverse Event
Death
Summary report: N
ITREL 3
MDR report key: 1190233
·
Received October 6, 2008
Report
- Report Number
- 3004209178-2008-06359
- Event Type
- Death
- Date Received
- October 6, 2008
- Date of Event
- November 16, 2000
- Report Date
- December 1, 2000
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS IN SEPTIC SHOCK DUE TO ENTEROBACTER CLOACAE ASSOCIATED WITH ISCHEMIC BOWEL. THE PT SUBSEQUENTLY EXPIRED FOLLOWING RESPIRATORY FAILURE. AN AUTOPSY WAS NOT PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LNQ | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7425G | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | IMPLANTED| EXPLANTED| LEAD MODEL 4300-35 LOT#PBP003783K| EXPLANTED| LEAD MODEL 4300-35 LOT# PBP003449K| IMPLANTED |