FDA Adverse Event
Injury
Summary report: N
VITALITY 2
MDR report key: 2042463
·
Received April 6, 2011
Report
- Report Number
- 2124215-2011-01383
- Event Type
- Injury
- Date Received
- April 6, 2011
- Date of Event
- January 17, 2011
- Report Date
- February 3, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE WAS EXPLANTED AND REPLACED. THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEVICE DECLARED THE BATTERY STATUS ELECTIVE REPLACEMENT INDICATORS (ERI) WITH A MONITORING VOLTAGE OF 2.62 VOLTS AND EXTENDED CHARGE TIME OF 22.5 SECONDS. SIX MONTHS PRIOR, THE MONITORING VOLTAGE WAS 2.92 VOLTS AND CHARGE TIME WAS 8.2 SECONDS. CURRENTLY THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 308 MO | Required Intervention | T177| 0157 |