FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 4140202
·
Received October 3, 2014
Report
- Report Number
- 2124215-2014-17201
- Event Type
- Malfunction
- Date Received
- October 3, 2014
- Date of Event
- June 30, 2014
- Report Date
- August 29, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- PMA / PMN Number
- P010012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED. HOWEVER, AT THIS TIME THERE IS NO FURTHER INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. AT THIS TIME THERE IS NO EVIDENCE THAT INTERVENTION HAS BEEN PERFORMED TO RESOLVE THIS ISSUE. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 619551 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | LWP | GUIDANT CRM CLONMEL IRELAND | N118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | H219| 4470| 0158| N118| 4525| 4088 |