BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 900 DR

    MDR report key: 3994233 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14929
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 16, 2013
    Report Date
    July 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PRODUCTS: 407658, LEAD, (B)(6) 2007; 3058, INTERSTIM URINARY MGU IPG, (B)(6) 2012; 3889-28, INTERSTIM URINARY MGU LEAD, (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN EMERGENT DEVICE CHANGEOUT DUE TO LOSS OF PROPER PACING AND APPARENT BATTERY DEPLETION ONLY ONE MONTH AFTER A NORMAL DEVICE CHECK. 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
    466712 KAPPA 900 DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC MED REL MEDTRONIC PUERTO RICO KDR901

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R 5568-53 LEAD