BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2791455 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14528
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 18, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 AND ANALYSIS FOUND THAT THE HELIX/LOBE WAS DISTORTED/BENT. THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY. THE OUTER INSULATION WAS BREACHED CUT. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND MECHANISM (SLEEVE HEAD). THE TURNS TO EXTEND/RETRACT THE HELIX EXCEEDED SPECIFICATION. VISUAL ANALYSIS NOTED THAT THE LEAD WAS DAMAGED AT IMPLANT. THE HELIX BEND LIKELY OCCURRED DURING IMPLANT OR REPOSITIONING OF THE LEAD. THE CUT IN THE OUTER INSULATION WAS LIKELY EXPLANT DAMAGE AND DIDN'T REACH THE CONDUCTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD DISLODGED AND HAD LOW R WAVES, HIGH THRESHOLDS AND LOW IMPEDANCE. AN ATTEMPT WAS MADE TO REPOSITION THE LEAD BUT AFTER THE HELIX WAS RETRACTED IT WOULD NOT EXTEND AGAIN. THE LEAD WAS EXPLANTED AND REPLACED. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB