BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1920769 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12331
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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): NO ANOMALIES FOUND. (B)(4): NO ANOMALIES FOUND, HOWEVER BLOOD AND TISSUE WERE NOTED ON HELIX MECHANISM; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF A DEVICE, 10 V PACING STIMULATION RESULTED IN A MUSCLE TWITCH UNDER THE CLAVICLE. THE LEAD WAS REMOVED AND REPLACED. IT WAS ALSO REPORTED THAT DEFIBRILLATION REQUIRED MORE THAN 30 JOULES AND THE DEVICE WAS NOT ABLE TO ACHIEVE THIS. THE FIRST DEVICE WAS REMOVED AND REPLACED WITH A SECOND DEVICE OF A MODEL WITH A HIGHER OUTPUT. NO PATIENT COMPLICATIONS WERE 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 LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other