FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 2944596
·
Received February 5, 2013
Report
- Report Number
- 2124215-2012-15857
- Event Type
- Injury
- Date Received
- February 5, 2013
- Date of Event
- January 26, 2012
- Report Date
- January 26, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- PMA / PMN Number
- P010012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 DURING A ROUTINE FOLLOW UP, THE RIGHT VENTRICULAR (RV) LEAD IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), EXHIBITED OUT OF RANGE IMPEDANCE MEASUREMENTS. THE POCKET WAS OPENED AND THE RV LEAD WAS REMOVED AND REINSERTED INTO THE HEADER WHICH RESOLVED THE ISSUE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48899 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| L| R | 0185| 4542| N119 |