FDA Adverse Event
Injury
Summary report: N
VITALITY AVT
MDR report key: 2051958
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-04121
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- July 5, 2005
- Report Date
- February 23, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS REMOVED DUE TO A PATIENT CONDITION WHICH DOES NOT REFLECT THE PERFORMANCE OF THE DEVICE.
Description of Event or Problem · 1
GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE DEVICE WAS EXPLANTED SECONDARY TO A PATIENT INFECTION. NEW INFORMATION RECEIVED INDICATES THAT THIS PATIENT HAS RETAINED LEGAL COUNSEL AND FILED A LAWSUIT. THERE WERE NO SPECIFIC ALLEGATIONS AGAINST THE FUNCTIONALITY OF THE DEVICE. THE PATIENT HAS SINCE PASSED AWAY DUE TO CANCER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY AVT | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | A155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | 4054| A155| 0174 |