BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2171493 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10109
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    September 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    AVAILABLE INFORMATION SUGGESTS THAT THIS SYSTEM REMAINS IMPLANTED AND IN SERVICE. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATES A REVISION PROCEDURE WAS PERFORMED. THE DEVICE WAS SUCCESSFULLY PLACED SUBPECTORALLY WITHOUT INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DEVELOPED AN INFECTION APPROXIMATELY THREE MONTHS LATER. A REVISION PROCEDURE WAS PERFORMED. THE SYSTEM WAS EXPLANTED AND A NEW SYSTEM WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS PRESENTED TO THE HOSPITAL WITH SKIN IRRITATION OVER THE DEVICE IMPLANT SITE. THE PATIENT REPORTED THAT THE PHYSICIAN OBSERVED THAT THE DEVICE HAD ERODED DUE TO INSUFFICIENT TISSUE. THE PATIENT WAS HOSPITALIZED AND GIVEN ANTIBIOTIC TREATMENT. CONSULTATION WITH A SURGEON IS PLANNED TO DISCUSS OPTIMAL PLACEMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R 4555| E110| 4592| 0185| 4136