BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3152729 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06678
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: 5076 IMPLANTABLE PACING LEAD 2008 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD STEADILY INCREASING IMPEDANCE. IT WAS ALSO REPORTED THAT THERE WAS AN INCREASE IN THRESHOLD. ISOMETRICS AND PROGRAMING OF THE RV LEAD IN UNIPOLAR RECOMMENDED. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT A VENTRICULAR LEAD IMPEDANCE WARNING WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252528 ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Life Threatening (B)(4) IMPLANTABLE PACEMAKER