BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1896479 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05067
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 26, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME EVENT. REFER TO MANUFACTURER REPORT # 3005099803-2010-04891 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. PATIENT ON 'DUODOPA' SINCE (B)(6) 2007 HAS USED SEVERAL DIFFERENT BRANDS OF PEG/J-TUBES WITH TREATMENT INTERRUPTION. A TITANOUS PORT WAS PLACED AND REJECTED AFTER APPROXIMATELY ONE MONTH. THE PATIENT HAD REPEATED INFECTIONS IN THE STOMA SITE WITH ALL SYSTEMS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR THE ADVANCED STAGE OF PARKINSON'S DISEASE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH AN INFECTION, IN THE STOMA SITE, WITHOUT ANY FEVER ALONG WITH INTERMITTENT MOTORIC FLUCTUATION. A CULTIVATION WAS TAKEN. THE EXACT DATE OF THE EVENT IS UNKNOWN HOWEVER; IT IS ESTIMATED TO BE AROUND (B)(6), 2010. ANTIBIOTIC TREATMENT WAS PRESCRIBED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010: PHYSICIAN STATES THAT THE INFECTIONS PROBLEMS WERE OUTSIDE THE STOMA SITE ON THE SKIN AND MAY BE DUE TO EXTRA SENSITIVE SKIN AND HYPERSENSITIVITY. THE RESULTS OF THE CULTIVATION THAT WAS TAKEN IN (B)(6) SHOWED (B)(6) (A LOT) ANTIBIOTIC TREATMENT WITH TABLET OF KÅVEPENIN. ON (B)(6) 2010 CULTIVATION WAS TAKEN AGAIN HOWEVER THE RESULTS ARE UNKNOWN; ANTIBIOTIC TREATMENT WAS PRESCRIBED, (EXACTLY WHAT WAS PRESCRIBED IS UNKNOWN). THIS DEVICE IS STILL IMPLANTED. THE PHYSICIAN IS TREATING THE INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED INCREASINGLY HIGH CAPTURE THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. ON INSPECTION OF THE EXPLANTED LEAD, A VISIBLE BREACH OF THE PROXIMAL INSULATION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/46

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention