FDA Adverse Event
Death
Summary report: N
LR-EVN-13.0
MDR report key: 1032536
·
Received April 22, 2008
Report
- Report Number
- 2522007-2008-00003
- Event Type
- Death
- Date Received
- April 22, 2008
- Date of Event
- March 20, 2008
- Report Date
- April 14, 2008
- Manufacturer
- COOK VASCULAR INC.
- Product Code
- DRE
- PMA / PMN Number
- K0601000
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS: NO CONCLUSION CAN BE DRAWN, DEVICE NOT RETURNED.
Description of Event or Problem · 1
AS REPORTED, "ATTEMPTED TO REMOVE ST. JUDE ICD LEAD, MODEL# 1580 USING 11 FR. EVOLUTION, SWITCHED TO 13 FR AFTER NOT PROGRESSING AT PROXIMAL COIL. EVENTUALLY GOT BEYOND COIL AND LEAD INSULATION PULLED APART. LOCKING STYLET STILL IN PLACE AND THE SHEATH WAS ABLE TO BE ADVANCED OVER STRETCHED INNER COIL AND DOWN TO DISTAL SHOCKING COIL OF LEAD. THE LEAD DID COME OUT ENTIRELY FROM THE HEART AND THE EVOLUTION SHEATH WAS REMOVED ALONG WITH THE LEAD. APPROX 5-10 MINS LATER, AS THE PT'S POCKET WAS BEING SEWED TOGETHER, THE PT LOST HER PULSE AND CPR BEGAN. A RIGHT SIDED CHEST TUBE WAS PLACED WITH A GOOD AMOUNT OF BLOOD RETURNING. PT SUBSEQUENTLY EXPIRED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LR-EVN-13.0 | LR-EVN-13.0 | DRE | COOK VASCULAR INC. | LR-EVN-13.0 | N73241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |