FDA Adverse Event
Injury
Summary report: N
VITALITY
MDR report key: 2042340
·
Received April 6, 2011
Report
- Report Number
- 2124215-2011-01359
- Event Type
- Injury
- Date Received
- April 6, 2011
- Date of Event
- January 19, 2011
- Report Date
- February 10, 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
THE DEVICE WAS LATER EXPLANTED FOR NORMAL BATTERY DEPLETION.
Additional Manufacturer Narrative · 1
INFORMATION SUGGEST THIS DEVICE REMAINS IN-SERVICE. INVESTIGATION IS COMPLETED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A VOLTAGE OF 2.64 AND CHARGE TIMES OF 25.3 SECONDS. THE PHYSICIAN WAS SURPRISED AND NOT COMFORTABLE WITH CHARGE TIMES OF THIS LENGTH. NO ADVERSE PATIENT EFFECTS WERE REPORTED. TECHNICAL SERVICES DISCUSSED THE ELECTIVE REPLACEMENT INDICATORS AND NOTED PHYSICIAN DISCRETION AS TO REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | T180| 6948 |