FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 2151268
·
Received July 6, 2011
Report
- Report Number
- 2124215-2011-06569
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 1, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- 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 THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVELOPED A POCKET INFECTION. A REVISION PROCEDURE WAS PERFORMED. THE DEVICE WAS TAKEN OUT, THE INFECTED AREA WAS TREATED AND THE DEVICE WAS RE-IMPLANTED UNDER THE PECTORAL MUSCLE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.
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 | 78 YR | Life Threatening| R | N118| 4469| 4517| H175| 0184 |