BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 4132368 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14529
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 21, 2014
    Report Date
    June 4, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    PMA / PMN Number
    P010012/S008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT WAS CONFIRMED TO BE RECEIVED AT OUR LOADING DOCK; AS OF TODAY, IT HAS NOT BEEN RECEIVED IN OUR QUALITY ASSURANCE LABORATORY. AS SUCH, ANALYSIS IS UNABLE TO BE COMPLETED ON THE PRODUCT AT THIS TIME. IF/WHEN THIS PRODUCT IS LOCATED, ANALYSIS WILL BE COMPLETED AT THAT TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO BE INTERROGATED WITH A PROGRAMMER AND DID NOT ELICIT BEEPING TONES WITH MAGNET PLACEMENT. IT WAS REPORTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW UP SINCE IMPLANT OF THE DEVICE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612958 CONTAK RENEWAL IMPLANTABLE DEVICE NIK BOSTON SCIENTIFIC CORPORATION H177 506818

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R 4193| H177| 1581| MISMATCH