FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 2936245
·
Received January 30, 2013
Report
- Report Number
- 2124215-2013-02190
- Event Type
- Malfunction
- Date Received
- January 30, 2013
- Date of Event
- December 31, 2012
- Report Date
- December 31, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
RECORDS INDICATE THIS DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECEIVED MULTIPLE INAPPROPRIATE SHOCKS FOR RHYTHM WHICH APPEARED TO BE ATRIAL DRIVEN AND THERAPY WAS EXHAUSTED. TECHNICAL SERVICES DISCUSSED DEVICE PROGRAMMING, DETECTION ENHANCEMENTS, AND REPROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41052 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | 4591| 4135| 0184| N119| 4554 |