FDA Adverse Event
Injury
Summary report: N
VITALITY 2
MDR report key: 1852657
·
Received October 4, 2010
Report
- Report Number
- 2124215-2010-14539
- Event Type
- Injury
- Date Received
- October 4, 2010
- Date of Event
- July 13, 2010
- Report Date
- July 13, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM REVIEWED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO POCKET EROSION. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD WAS IMPLANTED ON THE VENTRICLE; HOWEVER, IT WAS PLUGGED INTO THE ATRIAL PORT. IT WAS ALSO NOTED THAT THE PRODUCT WOULD NOT BE RETURNED FOR ANALYSIS.
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 | 76 YR | Required Intervention | T165| 1861| 0158| 4047| 7121| N119| (B)(4)| (B)(4)| 4554| 4470 |