BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

    MDR report key: 1902031 · Received November 18, 2010

    Report

    Report Number
    3005099803-2010-04891
    Event Type
    Injury
    Date Received
    November 18, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    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 # 3005099803-2010-04890 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 AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS BEING USED IN CONJUNCTION WITH THE J-TUBE FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR THE ADVANCED STAGE OF PARKINSON'S DISEASE. THE PEG KIT WAS PLACED ON (B)(6) 2009. 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. CORRECTION: THE PEG KIT WAS PLACED ON (B)(6) 2010. A NEW STOMA INCISION WAS MADE AT THAT TIME. 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 ON IN (B)(6) SHOWED BETA (B)(6) 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME EVENT. REFER TO MANUFACTURER REPORT # 3005099803-2010-04890 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 AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS BEING USED IN CONJUNCTION WITH THE J-TUBE FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR THE ADVANCED STAGE OF PARKINSON'S DISEASE. THE PEG KIT WAS PLACED ON (B)(6) 2009. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568381 12471972

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DUODOPA