BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2954311 · Received February 11, 2013

    Report

    Report Number
    2182208-2013-00437
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    October 29, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 APPROXIMATELY 2 MONTHS AFTER IMPLANT THE PATIENT REPORTED BLACKING OUT AND THAT THE DEVICE DID NOT GO OFF DUE TO FAULTY WIRING. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59012 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening