BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBQ

    MDR report key: 2811791 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03741
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND REVEALED THAT THE DEFIBRILLATION CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS TORN AND BREACHED DEPRESSION, THERE WAS TISSUE ON THE HELIX, AND THE LEAD WAS STRETCHED. THE ANALYST VISUAL COMMENT REVEALED: COULD NOT DETERMINE THE ANCHORING SLEEVE FIXATION SITE. .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS VARYING IMPEDANCE FROM THE LEAD. DURING REMOVAL IT WAS NOTED THAT THE PROXIMAL PART WAS FRACTURED AND THE COIL WAS NOTED TO BE "A LITTLE BIT UNCOILED." THE LEAD WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBQ IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6996

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R