FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 2041581
·
Received April 6, 2011
Report
- Report Number
- 2124215-2011-00950
- Event Type
- Injury
- Date Received
- April 6, 2011
- Date of Event
- January 12, 2011
- Report Date
- January 12, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 THIS PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REVISED AND PLACED SUB PECTORAL DUE TO A REPORTED EROSION. IT WAS LATER REPORTED THAT THE SUTURE SLEEVE HAD POPPED THROUGH THE SUTURES. THERE WAS VERY THIN SKIN OVER THE DEVICE. THE LEADS REMAIN UNCHANGED AT THIS TIME. NO OTHER PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention | 5076| N118| 4518| 6947| 7278 |