BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3152724 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01534
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    K790766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT FOR NORMAL BATTERY DEPLETION, THE PHYSICIAN DID NOT FULLY UNSCREW THE SETSCREW DUE TO USING THE WRONG SIZE WRENCH. WHEN THE PHYSICIAN PULLED ON THE LEAD TO REMOVE IT FROM THE HEADER, PART OF THE INSULATION PULLED AWAY IN THE CATHODE/TIP AREA, EXPOSING THE INNER WIRES. THE DAMAGED PORTION OF THE LEAD WAS CAPPED, AND THE UNDAMAGED ANODE PART REMAINS IN USE, UTILIZED FOR UNIPOLAR PACING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252268 ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 6901

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Hospitalization| R 9000 IMPLANTABLE PULSE GENERATOR