FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2
MDR report key: 2905461
·
Received January 9, 2013
Report
- Report Number
- 2124215-2012-13352
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- October 1, 2012
- Report Date
- October 2, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A LONGEVITY CALCULATION CONFIRMED THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW-VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY IDENTIFIED A PRODUCT PERFORMANCE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11862 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |