BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2053333 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05860
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND THE HELIX HAD DISENGAGED FROM THE HELICAL CHANNEL. IT WAS ALSO NOTED THAT THE INTER TUBING WAS KINKED/BUCKLED, AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE HELIX WAS EXTENDED, THEN RETRACTED AND WOULD NOT EXTEND AGAIN. THE PHYSICIAN ATTEMPTED MORE THAN 20 ROTATIONS TO TRY TO EXTEND THE HELIX. THE LEAD WAS ATTEMPTED, BUT NOT IMPLANTED AND A NEW LEAD WAS USED. 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 72 YR Other