BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2811906 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17393
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 16, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, TISSUE ON HELIX AND THE LEAD APPEARED DAMAGED AT IMPLANT. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH THE HELIX STRETCHED, DISTORTED/BENT. HOWEVER, THE HELIX WAS ABLE TO BE EXTENDED AND RETRACTED WITHIN SPECIFICATION. HELIX LENGTH OUT OF SPECIFICATIONS DUE TO HELIX DISTORTED/BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE HELIX OF THE LEAD WAS DIFFICULT TO EXTEND AND RETRACT. IT WAS NOTED THAT THE HELIX APPEARED TO NOT MOVE UNTIL THERE WAS MOVEMENT OF THE LEAD. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other 3058 INTERSTIM URINARY MGU IPG| 3889 INTERSTIM URINARY MGU LEAD