BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2122572 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07882
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    February 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND THE HELIX WAS DISENGAGED FROM HELICAL CHANNEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE IMPLANT, THE PHYSICIAN TESTED THE SCREW MECHANISM BEFORE INSERTING IT INTO THE PATIENT AND IT WORKED WELL. ONCE INSIDE THE PATIENT THE SCREW WOULD NOT EXTEND. THERE WERE MULTIPLE TRIES, BUT THE SCREW DID NOT EXTEND. THE LEAD WAS NOT IMPLANTED AND REPLACED WITH A NEW ONE. 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 LWS MEDTRONIC PUERTO RICO, INC. 6947M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other