BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1922997 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13173
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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) NO ANOMALIES WERE FOUND. HOWEVER THE INNER INSULATION WAS KINKED BUCKLED. THE OUTER INSULATION WAS BREACHED CUT AND HAD A WHITE SUBSTANCE ON IT AS WELL AS A COSMETIC DEPRESSION. THERE WAS APPARENT EXPLANT DAMAGE. THE PROXIMAL SEGMENT WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICLE LEAD HAS HIGH IMPEDANCE AND NOISE. ONE INAPPROPRIATE SHOCK WAS DELIVERED. THE LEAD WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R 1850 COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB