FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 3040665
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-00444
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- January 3, 2013
- Report Date
- January 3, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LEAD AND DEVICE REMAIN 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 THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD CAUSED A RED ALERT TO BE DETECTED DUE TO HIGH SHOCK IMPEDANCES GREATER THAN 125 OHMS. THE PATIENT'S PHYSICIAN IS AWARE OF THE SITUATION AND THE PATIENT WILL BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142862 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | P106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |