BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 900 DR

    MDR report key: 2790551 · Received October 15, 2012

    Report

    Report Number
    2647346-2012-01714
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. EVALUATION SUMMARY: (B)(4) PRELIMINARY ANALYSIS REVEALED NO OUTPUT AND NO TELEMETRY. FURTHER TESTING REVEALED THAT THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ATTEMPT TO INTERROGATE THE DEVICE BUT TELEMETRY WAS NEVER ESTABLISHED. IT WAS ASSUMED THAT THE BATTERY WAS AT END-OF-LIFE. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 900 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR901

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| D314TRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD