FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 2053354
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04105
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 3, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION IS EXPECTED REGARDING THIS EVENT, OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED AND REPLACED DUE TO THE DEVICE WAS REPLACED DUE TO PRESSURE NECROSIS AT THE POCKET SITE. THE LEADS WERE RECONNECTED TO THE REPLACEMENT DEVICE. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | P107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |