BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 900 SR

    MDR report key: 2053507 · Received April 13, 2011

    Report

    Report Number
    6000144-2011-01626
    Event Type
    Injury
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED TO REPORT HIS BATTERY WAS REPLACED "AFTER TWO YEARS" SUGGESTING POSSIBLE EARLY BATTERY DEPLETION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED TO REPORT HIS BATTERY WAS REPLACED "AFTER TWO YEARS" SUGGESTING POSSIBLE EARLY BATTERY DEPLETION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED DUE TO UNACCEPTABLE THRESHOLDS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 900 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KSR901 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD