BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2791077 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14492
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 7, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4). THE FULL LEAD WAS RETURNED, ANALYZED AND THE NUMBER OF TURNS TO EXTEND/RETRACT THE HELIX EXCEEDS SPECIFICATION. IT WAS NOTED THAT THE HELIX WAS CANTED AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE RIGHT VENTRICULAR LEAD R WAVE SENSING WAS NOT ACCEPTABLE AFTER PLACEMENT, SO THE HELIX WAS RETRACTED AND THE LEAD WAS PLACED IN A DIFFERENT LOCATION. THE HELIX WOULD NOT EXTEND AFTER MULTIPLE ATTEMPTS AT THE MAXIMUM RECOMMENDED NUMBER OF ROTATIONS. THE LEAD WAS REMOVED FROM THE PATIENT AND THE HELIX WOULD STILL NOT EXTEND. THE LEAD WAS NOT USED AND WAS REPLACED BY ANOTHER LEAD. 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 52 YR Other