BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERVENE

    MDR report key: 5419640 · Received February 9, 2016

    Report

    Report Number
    2124215-2016-01311
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Date of Event
    December 26, 2015
    Report Date
    April 5, 2016
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED INSULATION ABRASIONS. THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED STRESS OVER TIME. IN THIS CASE, WE BELIEVE THE STRESS WAS THE RESULT OF LEAD CONTACT WITH ANOTHER LEAD AND POSSIBLY WITH THE IMPLANTED DEVICE THE CAUSE OF THE HIGH IMPEDANCE MEASUREMENTS WAS NOT DETERMINED AS THE RETURNED PORTIONS OF THE LEAD WERE ELECTRICALLY CONTINUOUS AND OBSERVED DAMAGE TO THE CONDUCTOR COILS WERE RELATED TO THE EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. SHOCK IMPEDANCES ABRUPTLY INCREASED FROM 76 OHMS TO 187 OHMS. MEASUREMENTS REMAINED STABLE AT 187 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE CAUSES AND TROUBLESHOOTING OPTIONS. THE CAUSE OF THE INCREASE IN IMPEDANCE MEASUREMENTS WAS NOT DETERMINED. A SYSTEM REPLACEMENT PROCEDURE WAS PLANNED FOR A LATER DATE BUT HAS NOT BEEN SCHEDULED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING AN INVASIVE PROCEDURE WAS PERFORMED. THIS SYSTEM WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78092 INTERVENE IMPLANTABLE LEAD LWS GUIDANT ANGLETON/ST. PAUL 497-20

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR