BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2170338 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10326
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    April 28, 2011
    Report Date
    June 2, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    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 THIS DEVICE EXPERIENCED A LONGER THAN EXPECTED CHARGE TIME, HOWEVER IT WAS STILL WITHIN THE CHARGE TIME LIMIT. A MANUAL CAPACITOR REFORM WAS PERFORMED AND THE CHARGE TIME DECREASED. ONE MONTH LATER THE DEVICE REACHED ITS ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO AN EXTENDED CHARGE TIME OF 21.2 SECONDS. THE DEVICE WAS EXPLANTED FIVE DAYS LATER FOR NORMAL BATTERY DEPLETION. IT WAS NOTED THAT THE HOSPITAL SENT THE DEVICE HOME WITH THE PATIENT, SO IT WILL NOT BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 4517| 4469| H175| 0157