FDA Adverse Event
Injury
Summary report: N
VITALITY 2
MDR report key: 1954247
·
Received January 10, 2011
Report
- Report Number
- 2124215-2011-00010
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 16, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Removal / Correction Number
- Z-1513-08 TO Z-1514-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
A RETURN REQUEST WAS MADE FOR THIS PRODUCT. HOWEVER, THE REPRESENTATIVE REPORTED THAT THE DEVICE WILL NOT BE RETURNED AS IT WAS RETAINED BY THE HOSPITAL. 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) WAS EXPLANTED FOR NORMAL BATTERY DEPLETION WITH CHARGE TIMES OF 21.8 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 | T177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention | 0138| 6949| E102| T177 |