FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2
MDR report key: 2153440
·
Received July 7, 2011
Report
- Report Number
- 2124215-2011-06310
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 6, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE RECEIVED SIX BURSTS OF ANTI-TACHYCARDIC PACING AND FIVE SHOCKS FOR SINUS TACHYCARDIA. THERAPY WAS EXHAUSTED DUE TO THESE INAPPROPRIATE SHOCKS. THE LOCAL FIELD REPRESENTATIVE WAS NOT ABLE TO VIEW AN ELECTROGRAM FROM THE EPISODE DUE TO IT BEING OVERWRITTEN. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T167 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | T167| 0186| 4470 |