FDA Adverse Event
Injury
Summary report: N
VITALITY 2 DR
MDR report key: 711970
·
Received May 9, 2006
Report
- Report Number
- 2124215-2006-14586
- Event Type
- Injury
- Date Received
- May 9, 2006
- Date of Event
- February 13, 2006
- Report Date
- February 13, 2006
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS HOSPITALIZED DUE TO SYNCOPE CAUSED BY HYPOGLYCEMIA AND ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE PATIENT WAS TREATED WITH MEDICATION TO ADDRESS THE ATRIAL FIBRILLATION AND RELEASED FROM THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T165 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |