BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2131226 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10444
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THE LEAD WAS STRETCHED. IT WAS NOTED THAT THE INNER INSULATION WAS KINKED/BUCKLED AND THE LEAD APPEARED DAMAGED AT IMPLANT. THE ANALYST ALSO COMMENTED THAT THE LEAD HAS BEEN STRETCHED, SO THE INNER INSULATION BUCKLED AND PREVENTS THE HELIX FROM EXTENDING AND RETRACTING PROPERLY.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE PHYSICIAN WAS HAVING DIFFICULTY POSITIONING THE LEAD. WHEN ATTEMPTING TO REPOSITION THE HELIX ON THE LEAD WOULD NOT RETRACT. IT WAS ALSO NOTED THAT WHEN THE LEAD WAS REMOVED FROM THE BODY AND THE STYLET REMOVED THAT THE HELIX ALSO RETRACTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE PHYSICIAN WAS HAVING DIFFICULTY POSITIONING THE LEAD. WHEN ATTEMPTING TO REPOSITION THE HELIX ON THE LEAD WOULD NOT RETRACT. THE LEAD 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
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other