BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 700 DR

    MDR report key: 1864841 · Received October 12, 2010

    Report

    Report Number
    2647346-2010-00624
    Event Type
    Injury
    Date Received
    October 12, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 TESTING REVEALED ANOMALOUS OUTPUT CONDITIONS. THE NO OUTPUT CONDITION WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE HAD BEEN CHECKED IN (B)(6) 2010 AND WAS OK AT THAT TIME. THE MONITORING IN THE HOSPITAL ER DOCUMENTED EITHER NO VENTRICULAR OUTPUT OR INHIBITED PACING DUE TO OVERSENSING. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention 5024M IMPLANTABLE PACING LEAD| 5524M IMPLANTABLE PACING LEAD