FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL
MDR report key: 1870071
·
Received October 15, 2010
Report
- Report Number
- 2124215-2010-17649
- Event Type
- Malfunction
- Date Received
- October 15, 2010
- Date of Event
- August 20, 2010
- Report Date
- October 5, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Removal / Correction Number
- Z-0863-05
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
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Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) DEVELOPED AN INFECTION. THE LOCAL FIELD REPRESENTATIVE (FR) REPORTED THAT IT WAS UNCLEAR IF THE DEVICE WAS INVOLVED. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. THE DEVICE REMAINS IN SERVICE.
Description of Event or Problem · 1
SUBSEQUENT INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE INDICATED THAT THE FOLLOWING PHYSICIAN INDICATED THAT THERE WAS NOT AN INFECTION IN THE POCKET. THERE WAS NO INTERVENTION PERFORMED AND NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | H215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | H215| 0184| 4517| 4469 |