FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 1944817
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-21024
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- October 6, 2010
- Report Date
- October 6, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE AND LEAD REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE MEASUREMENTS WERE OBSERVED AT THE IMPLANT PROCEDURE FOLLOWING POCKET CLOSURE. THE POCKET WAS REOPENED AND A LOOSE CONNECTION BETWEEN THE DEVICE AND PROXIMAL COIL TERMINAL PIN WAS FOUND. THE PROXIMAL COIL TERMINAL PIN WAS REMOVED FROM THE DEVICE AND REINSERTED WITH ACCEPTABLE MEASUREMENTS OBSERVED. 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 | N119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |