BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 900 DR

    MDR report key: 2203665 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04561
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    June 6, 2013
    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
    OH, 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 FOR (B)(4): ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PACEMAKER WAS REPLACED BECAUSE IT WAS "BAD." THEY COULD NOT GET A READING FROM THE DEVICE. ALSO, THE PACEMAKER "FAILED AND WAS COMPLETELY DEAD." IT WAS CONFIRMED BY THE FIELD REPRESENTATIVE THAT THE DEVICE WAS UNABLE TO BE INTERROGATED BECAUSE THE BATTERY WAS COMPLETELY DEPLETED AND THERE WAS NO TELEMETRY. THE DEVICE WAS EXPLANTED AND THE PATIENT WAS UPGRADED FROM A PACEMAKER TO AN IMPLANTABLE CARDIAC DEFIBRILLATOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LAWSUIT ALLEGES THAT THE "DEVICE WAS DEFECTIVE AND HAD TO BE REPLACED." NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE LAWSUIT ALLEGES THAT "THE PACEMAKER MALFUNCTIONED CAUSING THE PATIENT PHYSICAL INJURIES AND SERIOUS EMOTIONAL DISTRESS. AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE PACEMAKER, THE PATIENT EXPERIENCED SEVERE PHYSICAL PAIN, SERIOUS EMOTIONAL DISTRESS, AND UNDERWENT AN EMERGENCY SURGERY."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 5076 X2 IMPLANTABLE PACING LEADS