FDA Adverse Event
Death
Summary report: N
ASKU
MDR report key: 1902639
·
Received November 18, 2010
Report
- Report Number
- 2183613-2010-00297
- Event Type
- Death
- Date Received
- November 18, 2010
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS IS 4 OF 14 EVENTS THAT OCCURRED AT THIS USER FACILITY. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
A CALL TO TECHNICAL SERVICES FROM THE BIOMEDICAL DEPARTMENT REPRESENTATIVE REPORTED, THE PHYSICIAN BELIEVES THE EXTERNAL PULSE GENERATORS (EPG) MAY BE INDUCING VENTRICULAR FIBRILLATION, AND TWO DEATHS HAVE BEEN NOTED. THE SERIAL NUMBER OF THE EPG CONNECTED TO PATIENTS AT THE TIME OF THESE UNTOWARD EVENTS IS UNKNOWN. THE CALLER FURTHER REPORTED, DEPARTMENT QUARTERLY CHECKS WERE COMPLETED AND FOUND NO ISSUES WITH THE EXTERNAL GENERATORS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASKU | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC MILACA INC. | 5388 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| H| L| R |