FDA Adverse Event
Injury
Summary report: N
VITALITY 2
MDR report key: 2172857
·
Received July 22, 2011
Report
- Report Number
- 2124215-2011-10216
- Event Type
- Injury
- Date Received
- July 22, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 9, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE HAD TWO NON-SUSTAINED ELECTROGRAMS WITH NOISE THAT OCCURRED THREE MONTHS APART. NOISE ON ONE OF THE ELECTROGRAMS WAS OVERSENSED RESULTING IN INHIBITION OF THERAPY FOR THREE SECONDS. IT WAS NOTED THAT PATIENT DID NOT HAVE AN UNDERLYING RHYTHM AND THIS CAUSED THE SHOCK ELECTROGRAM TO APPEAR FLAT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Life Threatening | 5568| 0185| T165 |