FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 1952822
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-24543
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 6, 2010
- Report Date
- December 6, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCTS REMAIN IMPLANTED. 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 WITH THIS DEVICE AND RIGHT VENTRICULAR LEAD EXPERIENCED A SYNCOPAL EPISODE AND WAS HOSPITALIZED. NOISE RESULTING IN OVERSENSING WITH A PACED RATE IN THE 20'S WAS RECORDED THREE MONTHS PRIOR. THE PATIENT IS PACEMAKER DEPENDENT. TECHNICAL SERVICE WAS CONTACTED AND DISCUSSED PROGRAMMING OPTIONS SINCE THE PATIENT WAS NOT A GOOD SURGICAL CANDIDATE.
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 | 76 YR | Hospitalization | 1297| 4015| 4456| 1283| 4543| N119| 0158 |