BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1952573 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23629
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 28, 2006
    Report Date
    December 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC. 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 FROM THE PATIENT'S SPOUSE THAT THE PHYSICIAN STATED THIS DEVICE WAS DEFECTIVE. THE PATIENT HAD SEVERAL ARRHYTHMIAS WHICH THIS DEVICE DID NOT DELIVER THERAPY FOR. THE PATIENT NEEDED A HEART TRANSPLANT AND WAS TOLD BY HIS PHYSICIAN THAT HE WOULD NEED HIS DEVICE REPLACED IF HE DID NOT GET THE TRANSPLANT. THE PATIENT LATER UNDERWENT A HEART TRANSPLANT PROCEDURE. THE DEVICE WAS EXPLANTED AND THE LEADS WERE SURGICALLY ABANDONED. THE PATIENT LATER PASSED AWAY. THE CAUSE OF DEATH WAS NOT DISCLOSED. THE PATIENT'S SPOUSE HAS THE DEVICE IN HER POSSESSION. TECHNICAL SERVICES DISCUSSED THAT THE DEVICE CAN BE ANALYZED FOR PERFORMANCE CONCERNS IF IT IS RETURNED TO BOSTON SCIENTIFIC.

    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 67 YR 0145| 4513| H175| 4469| 1790