FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL
MDR report key: 2153347
·
Received July 7, 2011
Report
- Report Number
- 2124215-2011-06181
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 7, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER AN IMPLANT PROCEDURE OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE PATIENT DEVELOPED A POCKET INFECTION AND THEN BECAME HOSPITALIZED. ANTISEPTIC DRESSINGS WERE PLACED ON THE POCKET INFECTION. THE PATIENT WAS LATER DISCHARGED FROM THE HOSPITAL. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | H190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |