FDA Adverse Event
Death
Summary report: N
STRYKER PAINPUMP
MDR report key: 522822
·
Received April 27, 2004
Report
- Report Number
- 1811755-2004-00023
- Event Type
- Death
- Date Received
- April 27, 2004
- Date of Event
- November 6, 2002
- Report Date
- March 29, 2004
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- MEB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
PLANTIFF'S ATTORNEY REPORTED AN INCIDENT WHICH OCCURRED OVER A YEAR AGO. THE REPORT ALLEGES THE PT HAD A PAINPUMP PLACED FOLLOWING A TOTAL SHOULDER ARTHROPLASTY. THE PT WENT INTO VENTRICULAR TACHYCARDIA A 1/2 HOUR AFTER THE PUMP WAS PLACED. A CODE WAS CALLED AND CPR WAS INITIATED. THE PT COULD NOT BE RESUSCITATED AND WAS PRONOUNCED DEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER PAINPUMP | INFUSION PUMP | MEB | STRYKER INSTRUMENTS | 0500-120-000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Death |