BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE G PASSIVE DUAL COIL 59CM

    MDR report key: 1682714 · Received May 7, 2010

    Report

    Report Number
    2124215-2010-04037
    Event Type
    Injury
    Date Received
    May 7, 2010
    Date of Event
    March 2, 2009
    Report Date
    August 5, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TECHNICAL SERVICE RECOMMENDED DELIVERING A MINIMUM AND MAXIMUM ENERGY SHOCK TO TEST THE SYSTEM. THE AVAILABLE INFORMATION SUGGESTS THE SHOCK PORTION OF THIS LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE RATE/SENSE PORTION OF THE LEAD HAD PREVIOUSLY BEEN REPLACED DUE TO NOISE AND DECREASING PACE IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING AN INVASIVE PROCEDURE WAS PERFORMED. THIS SHOCK PORTION OF THE LEAD WAS SURGICALLY ABANDONED DUE TO THE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE RATE/SENSE PORTION OF THE LEAD HAD PREVIOUSLY BEEN SURGICALLY ABANDONED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE G PASSIVE DUAL COIL 59CM IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0174 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R DEVICE T180/206576