FDA Adverse Event
Injury
Summary report: N
VITALITY 2
MDR report key: 2040111
·
Received April 5, 2011
Report
- Report Number
- 2124215-2011-00800
- Event Type
- Injury
- Date Received
- April 5, 2011
- Date of Event
- January 6, 2011
- Report Date
- January 4, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
THIS DEVICE HAS NOT YET BEEN RETURNED. SHOULD THE DEVICE BE RETURNED AND ANALYSIS OR NEW INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED ONE YEAR LATER FOR NORMAL BATTERY DEPLETION (NBD).
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE HEALTH CARE PROVIDER SUSPECTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS DEPLETING PREMATURELY. NO ACTION WAS TAKEN AT THIS TIME. THE DEVICE REMAINS IMPLANTED AND WILL CONTINUE TO BE MONITORED. 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 | 73 YR | Hospitalization| L| R | 4086| T165| 0184 |