FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 1950394
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22362
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- August 4, 2010
- Report Date
- November 16, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED SYSTEM WAS NOT RETURNED TO BOSTON SCIENTIFIC. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, RIGHT VENTRICULAR DEFIBRILLATION LEAD, AND ATRIAL LEAD WERE EXPLANTED DUE TO INFECTION. APPROXIMATELY ONE MONTH LATER A NEW PACING SYSTEM WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | P108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |