FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 2911465
·
Received January 11, 2013
Report
- Report Number
- 2124215-2012-16031
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Date of Event
- November 25, 2012
- Report Date
- November 26, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED A HIGH OUT OF RANGE PACING IMPEDANCE FOR THIS PATIENT'S NON BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. THE LEAD IS BELIEVED TO BE FRACTURED AND THERE WAS GREATER THAN TWO SECONDS OF ASYSTOLE NOTED AS A RESULT. THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17738 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | H175| N118| MISMATCH| 6949| 4518 |