FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 3771412
·
Received April 24, 2014
Report
- Report Number
- 2124215-2014-09088
- Event Type
- Malfunction
- Date Received
- April 24, 2014
- Date of Event
- June 24, 2010
- Report Date
- February 20, 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
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 CRM RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2,000 OHMS. NO NOISE WAS NOTED ON THE LEAD, AND ALL OTHER LEAD MEASUREMENTS WERE WITHIN NORMAL RANGE. A REVISION PROCEDURE WAS LATER PERFORMED AND THE DEVICE SYSTEM WAS EXPLANTED DUE TO EXTRACTION. THIS WAS DOCUMENTED IN REPORT #2124215-2012-05795.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248931 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | LWP | GUIDANT CRM CLONMEL IRELAND | N119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | 4555| 4087| 0185| N119 |