FDA Adverse Event
Malfunction
Summary report: N
VITALITY
MDR report key: 2173739
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10768
- Event Type
- Malfunction
- Date Received
- July 23, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 20, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCT REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED THE END OF LIFE DUE TO THE CHARGE TIME MEASUREMENTS EXCEEDING THE EXTENDED CHARGE TIME LIMIT. THE MONITORING VOLTAGE WAS ABOVE THE ELECTIVE REPLACEMENT INDICATOR VOLTAGE AND THE CHARGE TIME WAS GREATER THAN 30 SECONDS. THE DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATOR ADVISORY POPULATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | 0155| T135| 1790| 0145 |