BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1926143 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14195
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 19, 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
    CA, 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 FOUND THAT THE HELIX DISENGAGED FROM THE HELICAL CHANNEL. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE DISTAL CONDUCTOR FRACTURED DUE TO OVERSTRESS, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THERE WAS A TIP SEAL OBSERVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HELIX WOULD NOT RE-DEPLOY AFTER ATTEMPTING TO REPOSITION THE LEAD DURING IMPLANT. LEAD WAS EXPLANTED AND REPLACED. AS A RESULT OF THE EXPLANT PROCEDURE THERE WAS APPARENT DAMAGE TO THE INSULATION. 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 79 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PACING LEAD