BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 900 DR

    MDR report key: 3862419 · Received June 10, 2014

    Report

    Report Number
    2647346-2014-00054
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. CONCOMITANT PRODUCT: 1188T COMPETITOR LEAD, IMPLANTED: (B)(6) 1997. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WAS RECEIVING ECT (ELECTRO-CONVULSIVE THERAPY) FOR DEPRESSION, THE DEVICE EXHIBITED A POR (POWER ON RESET) AND STOPPED WORKING AT THE TIME OF ECT. INTERROGATION OF THE DEVICE SHOWED THE POR AND THAT THE DEVICE HAD REACHED ERI (ELECTIVE REPLACEMENT INDICATOR) ABOUT 14 MONTHS EARLIER. THE DEVICE STOPPED PACING WHEN THE PROGRAMMING HEAD WAS APPLIED, AND NO CAPTURE WAS NOTED ALONG WITH UNDEFINED HIGH RV (RIGHT VENTRICULAR) LEAD IMPEDANCE. 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
    337921 KAPPA 900 DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MDT PUERTO RICO OPERATIONS CO, MED REL KDR901

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R 1188T COMPETITOR LEAD