BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790379 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14409
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 25, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. EVALUATION SUMMARY: (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS DISTORTED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE HELIX/LOBE WAS DISTORTED/BENT, THERE WAS APPARENT EXPLANT DAMAGE AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. ANALYST VISUAL COMMENT: LEAD RECEIVED WITH THE HELIX EXTENDED AND BENT. BLOOD IN THE DISTAL CONDUCTOR LIKELY ENTERED THROUGH THE IS-1 PIN AS NO INSULATION BREACH WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT, THE HELIX WOULD NOT RETRACT. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. 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. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other