BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3904275 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12968
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE LOCAL REPRESENTATIVE, THE DEVICE WILL NOT BE RETURNED AS THE HOSPITAL NO LONGER HAS THE DEVICE. THE LOCAL REPRESENTATIVE WAS NOT AWARE OR HAD NOT BEEN NOTIFIED OF ANY COMPLICATIONS THAT MAY HAVE OCCURRED AS A RESULT OF THE REPLACEMENT PROCEDURE. 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 PATIENT CONTACTED BOSTON SCIENTIFIC'S WARRANTY DEPARTMENT. ACCORDING TO THE PATIENT, THIS DEVICE WAS FAULTY AND REQUIRED REPLACEMENT. THE PATIENT WAS INFORMED THAT BOSTON SCIENTIFIC WOULD COVER THE EXPENSE OF THE REPLACEMENT DEVICE. THE WARRANTY DEPARTMENT WAS INFORMED THAT THE PATIENT HAD EXPERIENCED SOME COMPLICATIONS AS A RESULT OF THE REPLACEMENT PROCEDURE. COMPLICATIONS INCLUDED AN ALLERGIC REACTION TO THE DRESSING AND TAPE THAT WAS PLACED OVER THE POCKET SITE. ADDITIONALLY, A LARGE BRUISE DEVELOPED AROUND THE POCKET SITE. THE PATIENT MENTIONED THE POSSIBILITY OF SEEKING LEGAL CONSULTATION. THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC AND INFORMATION ON THE IMPLANT FORM INDICATES THE REASON FOR EXPLANT AS NORMAL BATTERY DEPLETION. IT APPEARS THAT THE PATIENT MAY HAVE RECEIVED INCORRECT INFORMATION FROM THE BOSTON SCIENTIFIC FIELD CLINICAL REPRESENTATIVE. (FCR). PRIOR TO EXPLANT, THE DEVICE WAS INTERROGATED BY THE LOCAL REPRESENTATIVE. THERE WERE NO ERROR MESSAGE OR FAULT CODES DISPLAYED UPON INTERROGATION. THE FCR AND THE PHYSICIAN WERE NOTIFIED OF THE FINDINGS FROM DEVICE INTERROGATION AND THAT THE DEVICE DID NOT NEED REPLACEMENT. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE DEVICE DESPITE THE FINDINGS THAT THE DEVICE DID NOT DISPLAY ANY ERROR MESSAGES, FAULT CODES AND DID NOT TRIGGER REPLACEMENT INDICTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384997 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 1831| 0125| E163| E110| A155| 438-10