FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 1944610
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-19900
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- October 8, 2010
- Report Date
- October 8, 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 PACING SYSTEM REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A WOUND REVISION WAS PERFORMED AS THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR APPEARED TO BE SHOWING SIGNS OF EROSION AS THE SKIN WAS DISCOLORED AND STRETCHED AT THE BASE OF THE DEVICE. A LOW GRADE INFECTION WAS ALSO PRESENT. THE DEVICE POCKET WAS IRRIGATED WITH BETADINE AND THE DEVICE WAS REPOSITIONED SUBPECTORALLY. NO 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 | N108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |