BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1855013 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09162
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 25, 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 Location
    GA, 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 LEAD 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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS DISTORTED. IT WAS NOTED THAT SEVERAL CONDUCTORS WERE DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE SLEEVE HEAD, AND THE HELIX MECHANISM, THE HELIX WAS BENT, AND DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HELIX "SCREW MECHANISM" ON THE LEAD WAS "FROZEN." IT WAS FURTHER REPORTED THAT THERE WAS NO EVIDENCE ON FLUORO OF THE HELIX ADVANCING. THE PHYSICIAN TRIED SEVERAL TIMES, AND AT ONE POINT, LET GO, AND THE PINCH-ON TOOL "FLIPPED AROUND" MANY TIMES, RELEASING THE PRESSURE. FURTHER ATTEMPTS TO ADVANCE THE HELIX AFTER REPOSITIONING WERE ALSO UNSUCCESSFUL. ONCE REMOVED, THE LEAD WAS INSPECTED, AND IT SHOWED THAT THE TIP HAD A "BEND TO IT." ANOTHER ATTEMPT WAS MADE TO EXTEND THE HELIX, AND AFTER APPROXIMATELY 25 TURNS, IT SUDDENLY POPPED OUT. THE LEAD WAS NOT USED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    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 Other| R