FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 1766349
·
Received July 21, 2010
Report
- Report Number
- 2124215-2010-12199
- Event Type
- Injury
- Date Received
- July 21, 2010
- Date of Event
- May 27, 2010
- Report Date
- May 27, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE SHOCKING VECTOR WAS PROGRAMMED TO DISTAL COIL TO CAN. THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), IMPLANTED WITH ANOTHER MANUFACTURER'S DEFIBRILLATION LEAD, EXHIBITED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS ONE DAY POST IMPLANT. SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OMHS WERE OBSERVED IN TRIAD AND COIL TO COIL SHOCKING VECTORS. WHEN THE SHOCKING VECTOR WAS PROGRAMMED TO DISTAL COIL TO CAN THE SHOCK IMPEDANCE MEASUREMENT WAS ACCEPTABLE. 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 | 75 YR | MISMATCH| N119| (B)(4)| (B)(4)| 4592 |