FDA Adverse Event
Injury
Summary report: N
VITALITY 2
MDR report key: 1952542
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-23234
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- October 5, 2010
- Report Date
- December 3, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UPON ADDITIONAL INFORMATION THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD AN ATRIAL FIBRILLATION ARRHYTHMIA WHICH ACCELERATED TO A VENTRICULAR FIBRILLATION ARRHYTHMIA AND THE PATIENT EXPERIENCED SYNCOPE. AT THIS TIME NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | T175| 0181 |