BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2864859 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17555
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    October 18, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    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. (B)(4): CONCOMITANT PRODUCT: (B)(4) IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE OF THE RIGHT ATRIAL (RA) LEAD HAS INCREASED OVER THE PAST YEAR AND AN ALERT TRIGGERED. THRESHOLD HAS ALSO BEEN FLUCTUATING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS CO. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR 7121 COMPETITOR IMPLANTABLE TACHY LEAD