BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IROX

    MDR report key: 3904162 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09898
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 6, 2014
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    DTB
    PMA / PMN Number
    K890412
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION NOTED THAT ONLY THE PROXIMAL SEGMENT OF THIS LEAD WAS RETURNED SEVERED APPROXIMATELY 9.2 CM FROM THE TERMINAL PIN. THE OUTER INSULATION WAS BREACHED, CRACKED, AND APPEARED TO FROSTED YELLOW IN COLOR IN MULTIPLE LOCATIONS ALONG THE RETURNED SEGMENT. THE CONDITION WAS ATTRIBUTED TO ENVIRONMENTAL STRESS CRACKING AND MAY HAVE BEEN COMPOUNDED BY THE EXPLANT PROCEDURE. THE OUTER COIL WAS STRETCHED BETWEEN 5 AND 7 CM FROM THE TERMINAL PIN. AT APPROXIMATELY 9 CM FROM THE THE TERMINAL PIN THE OUTER INSULATION WAS BREACHED AND APPEARED TO BE MELTED, LIKELY FROM ELECTROCAUTERY DAMAGE. THERE WAS NO MELTING NOTED IN THE CONDUCTORS. A SHARP BEND IN THE RETURNED LEAD SEGMENT WAS ALSO OBSERVED, BUT THE SEGMENT PASSED ELECTRICAL CONTINUITY TESTING. THE LEAD TERMINAL PIN WAS TESTED WITH THE DEVICE HEADER AND PASSED. THE LEAD REMOVAL DIFFICULTY COULD NOT BE CONFIRMED IN ANALYSIS, HOWEVER, LEAD INSULATION ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DEPENDANT PATIENT WAS RECENTLY SEEN AND THEIR DEVICE COULD NOT BE INTERROGATED NOR WOULD IT RESPOND TO A MAGNET APPLICATION. AN ELECTROCARDIOGRAM WAS DONE WHICH SHOWED PACING AT 65 BPM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED PACING AT 65BPM IS UNUSUAL AND WOULD ONLY BE LIKELY IF THERE WAS A POWER ON RESET. THE PATIENT DID RECENTLY HAVE ROTATOR CUFF SURGERY IN WHICH IT IS BELIEVED THAT THERE MIGHT HAVE BEEN ELECTROCAUTERY USED WHICH COULD HAVE CAUSED A RESET ON THE DEVICE. THE PHYSICIAN MADE THE DECISION TO EXPLANT IMMEDIATELY. DURING THE EXPLANT PROCEDURE, THERE WAS DIFFICULTY REMOVING THE RIGHT VENTRICULAR (RV) LEAD FROM THE DEVICE HEADER AND THE PHYSICIAN STATED THE INSULATION HAD MELTED AND THEY COULD NOT REMOVE THE LEAD FROM THE DEVICE HEADER. AS A RESULT THE LEAD WAS SURGICALLY ABANDONED. TS SUSPECTED THAT IF THERE WAS MELTING OF THE LEAD, THAT MEANT THAT THERE WAS ENERGY ON THE LEAD AND IT MAY HAVE SOMEHOW GOTTEN BACK INTO THE DEVICE AND EFFECTED TELEMETRY AND OR CIRCUITRY. THE NEW SYSTEM WAS SUCCESSFULLY IMPLANTED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382951 IROX IMPLANTABLE LEAD DTB GUIDANT ANGLETON/ST. PAUL 430-07

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 1198| (B)(4)| 1174| (B)(4)