FDA Adverse Event
Injury
Summary report: N
VITALITY 2
MDR report key: 2050222
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-03326
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 18, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED PRODUCTS WERE NOT RETURNED TO BOSTON SCIENTIFIC. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND RIGHT VENTRICULAR DEFIBRILLATION LEAD WERE EXPLANTED DUE TO AN INFECTION OF THE DEVICE POCKET. THE LEAD HAD PASSED THROUGH THE SKIN AND THE POCKET WAS SECRETING. NO ADDITIONAL 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 | T175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |