FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 1952844
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-24181
- Event Type
- Malfunction
- Date Received
- January 7, 2011
- Date of Event
- December 7, 2010
- Report Date
- December 7, 2010
- 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 THRESHOLD MEASUREMENT TEST RADIO FREQUENCY (RF) TELEMETRY WAS LOST MOMENTARILY AND LOSS OF CAPTURE (LOC) AND ASYSTOLE WAS NOTED FOR EIGHT SECONDS. THE TEST WAS ABLE TO BE COMPLETED AND 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 | 4574| KDR901| 4549| N119| 4543| 4074| 0185 |