BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2952196 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00466
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 13, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. (B)(4) IMPLANTABLE PULSE GENERATOR 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD HAD LOW IMPEDANCES WHICH CAUSED A LEAD POLARITY SWITCH. 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
    55680 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR 5076 IMPLANTABLE PACING LEAD