BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992423 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09899
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    February 4, 2011
    Report Date
    May 16, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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: 5076-58 LEAD, IMPLANTED: (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVIEW OF THE IMPLANTABLE PULSE GENERATOR (IPG) AT END OF LIFE (EOL) INDICATED THAT THERE HAS BEEN OCCASIONAL NOISE ON THE ATRIAL AND/OR VENTRICULAR LEADS OVER THE LIFE OF THE DEVICE, INCREASING OVER THE FEW MONTHS PRIOR TO EXPLANT. THE PHYSICIAN SUSPECTS A LOOSENING SET SCREW. THE NOISE COULD NOT BE DUPLICATED ON THE LEADS AFTER 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
    467714 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR KDR901 IPG