BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2951887 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00248
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4) - THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE LEAD WAS DISTORTED. THE HELIX WAS PULLED/STRETCHED/OVERSTRESSED. THERE WAS APPARENT DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE HELIX SNAGGED THE INTRODUCER'S VALVE. THE HELIX APPEARED TO HAVE BEEN STRETCHED AND WOULD NOT FULLY RETRACT. THE LEAD WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55992 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR