BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2813183 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16984
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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: (B)(4) - THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THE HELIX/LOBE WAS DISTORTED/BENT AND VISUAL ANALYSIS NOTED THAT THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE IMPLANT PROCEDURE, THE PHYSICIAN ATTEMPTED TO EXTEND THE HELIX ON THE LEAD. THE HELIX SEEMED TO BUILD UP TORQUE AT THE TIP BUT WOULD NOT EXTEND. THE PHYSICIAN REVERSED THE ROTATIONS AND TRIED AGAIN BUT THE HELIX WAS INCONSISTENT IN EXTENDING AND RETRACTING. THE LEAD WAS NOT 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 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD NVY MEDTRONIC PUERTO RICO, INC. 6947M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other