FDA Adverse Event
Other
Summary report: N
VENTAK MINI III AICD
MDR report key: 266506
·
Received February 22, 2000
Report
- Report Number
- MW1018286
- Event Type
- Other
- Date Received
- February 22, 2000
- Date of Event
- February 1, 2000
- Report Date
- February 22, 2000
- Manufacturer
- CARDIAC PACEMAKERS, INC. GUIDANT CORP.
- Product Code
- LWS
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ADD'L INFO REC'D FROM MFR 4/3/00: THE DEVICE PERFORMED NORMALLY DURING TESTING AND WAS FOUND TO BE FUNCTIONING WITHIN SPEC. THE MEDWATCH FORM STATES THE DEVICE WAS PROPHYLACTICALLY REMOVED FOLLOWING A SAFETY ALERT ISSUE FOR SUCH DEVICES IMPLANTED SUBPECTORALLY. FOLLOW-UP WITH THE RPTR HAS FOUND THAT THE PT FULLY RECOVERED AND HAS EXPERIENCED NO FURTHER ADVERSE EVENTS. THE ICD WAS IMPLANTED IN 1999 AND REMOVED IN 2000. TOTAL IMPLANT DURATION WAS 9.1 MONTHS.
Description of Event or Problem · 1
VENTAK MINI III AICD MODEL #1782 AND #1786: SAFETY ALERT ISSUED FOR THOSE AICD'S IMPLANTED SUBPECTORALLY. PT PRESENTED FOR ELECTIVE AICD REPLACEMENT FOLLOWING MINI III SAFETY ALERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTAK MINI III AICD | AUTOMATIC IMPLANTABLE DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC. GUIDANT CORP. | 1782 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |