FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 2051672
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-03630
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- July 19, 2010
- Report Date
- February 20, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE AVAILABLE INFORMATION SUGGESTS 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 INAPPROPRIATE ANTITACHYCARDIA PACING (ATP), FOLLOWED BY MULTIPLE SHOCKS IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. IT WAS REPORTED THAT THERAPY WAS EXHAUSTED. TECHNICAL SERVICES DISCUSSED DETECTION ENHANCEMENTS AND POTENTIAL REPROGRAMMING OPTIONS. 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 | 67 YR | 4470| 7121| 4592| (B)(4)| N119 |