BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK SQ

    MDR report key: 3209472 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09069
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS NOT PRESENT FOR THE CASE. IT WAS REPORTED TO THE FIELD REPRESENTATIVE THAT THIS PATIENT HAD A SQ ARRAY LEAD AND THE SUPERIOR SHOCKING ELEMENT WAS VERY SUPERFICIAL WHEN IMPLANTED. THE PATIENT PRESENTED TO THE HEALTH CARE FACILITY AND THE SUPERIOR ELEMENT HAD ERODED THROUGH THE SKIN UNDER THE AXILLA; ALSO, THERE WAS PUS IN THE POCKET THAT WOULD COME OUT WITH ARM MOVEMENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM, WHERE THE PHYSICIAN TUNNELED DOWN AND CLIPPED THE SUPERIOR ELEMENT OFF, PLACED MEDICAL ADHESIVE AND CAPPED THAT PORTION. FROM THE EXPOSED AREA UNDER THE AXILLA THE DISTAL, NON-CAPPED, PORTION WAS EXPLANTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED WITH THE FIELD REPRESENTATIVE THAT IT WAS THE PHYSICIAN¿S DISCRETION TO DO THIS, BUT THAT IT CANNOT BE GUARANTEED IT WILL WORK AS THE PRODUCT WAS ALTERED. REPORTEDLY, THE PHYSICIAN THOUGHT THE SYSTEM WOULD WORK BETTER BECAUSE THE SUPERIOR ELEMENT WAS REMOVED AND THERE WOULD BE A DECREASE IN THE SPREAD OF THE CURRENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IMPLANTED, WITH THE SUPERIOR ELEMENT OF THIS LEAD CAPPED, THE MEDIAL AND INFERIOR ELEMENTS REMAIN IN SERVICE AND ACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310231 ENDOTAK SQ IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0085

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R E110| 0181| 4473| 0085