FDA Adverse Event
Injury
Summary report: N
VITALITY 2
MDR report key: 1950380
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22337
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 15, 2010
- Report Date
- November 15, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Removal / Correction Number
- Z-0047-2008 TO Z-0053-20
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATOR ADVISORY, TRIGGERED END OF LIFE (EOL) WITH A MONITORING VOLTAGE OF 2.55 VOLTS AND CHARGE TIME MEASUREMENTS OF 32.5 SECONDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | 5076| T165| 6943 |