BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 700 DR

    MDR report key: 2813584 · Received October 31, 2012

    Report

    Report Number
    2647346-2012-01778
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) THE DEVICE WAS RETURNED, ANALYZED, AND THE EMA WIREBOND WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED (NO TELEMETRY). THE DEVICE WAS EXPLANTED AND REPLACED. 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 700 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR701

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R 4024 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD