FDA Adverse Event
Death
Summary report: N
COGNIS
MDR report key: 1722434
·
Received June 14, 2010
Report
- Report Number
- 2124215-2010-12300
- Event Type
- Death
- Date Received
- June 14, 2010
- Date of Event
- June 8, 2010
- Report Date
- June 8, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
DUE TO THE NATURE OF THIS ISSUE, NO ANALYSIS IS SCHEDULED TO BE CONDUCTED IF THE DEVICE IS RETURNED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT THIS PATIENT WAS DIAGNOSED WITH AN INFECTION, AND PASSED AWAY DURING A SUBSEQUENT SURGICAL ATTEMPT TO EXTRACT THE ASSOCIATED LEADS. IT WAS REPORTED THE PATIENT¿S SUPERIOR VENA CAVA WAS TORN DURING THE USE OF THE LEAD EXTRACTION TOOL. THERE WERE NO ALLEGATIONS AGAINST THIS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death | 4543| N119| 0157| 4054 |