FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 2052593
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-03502
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- January 3, 2011
- Report Date
- February 24, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE IMPLANT PROCEDURE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE REPORTED. THE SET SCREWS WERE CHECKED THREE TIMES AND APPEARED TO BE ADEQUATELY TIGHTENED. UPON CHECKING AGAIN, NORMAL IMPEDANCE MEASUREMENTS WERE REPORTED FROM THE RV LEAD TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE. THE LEAD AND DEVICE WILL CONTINUE TO BE MONITORED. 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 | 58 YR | 4542| 0184| 4136| N119 |