BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2044369 · Received April 7, 2011

    Report

    Report Number
    3005099803-2011-01093
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PULL METHOD KIT WAS BEING USED IN CONJUNCTION WITH A J-TUBE FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR THE ADVANCED STAGE OF PARKINSON'S DISEASE. THE PATIENT HAS BEEN USING BOSTON SCIENTIFIC PEG/J-TUBES SINCE 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT HAS HAD REPEATED INFECTION PROBLEMS. APPROXIMATELY AROUND (B)(6), 2011 THE INTERNAL BOLSTER WAS BURIED IN THE STOMACH WALL MUCOSA AND THE PATIENT PRESENTED WITH AN INFECTION. THE PEG/J-TUBE WAS REMOVED. WHEN THE STOMA HAS HEALED A NEW PEG/J-TUBE WILL BE PLACED (THE MANUFACTURER IS UNKNOWN AT THIS TIME). THE PATIENT WAS NOT HOSPITALIZED DUE TO THIS EVENT. THE PATIENT RECEIVED A NASOINTESTINAL TUBE SO THAT THE DUODOPA TREATMENT COULD CONTINUE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PULL METHOD KIT WAS BEING USED IN CONJUNCTION WITH A J-TUBE FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR THE ADVANCED STAGE OF PARKINSON'S DISEASE. THE PATIENT HAS BEEN USING BOSTON SCIENTIFIC PEG/J-TUBES SINCE 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT HAS HAD REPEATED INFECTION PROBLEMS. APPROXIMATELY AROUND (B)(6), 2011 THE INTERNAL BOLSTER WAS BURIED IN THE STOMACH WALL MUCOSA AND THE PATIENT PRESENTED WITH AN INFECTION. THE PEG/J-TUBE WAS REMOVED. WHEN THE STOMA HAS HEALED A NEW PEG/J-TUBE WILL BE PLACED (THE MANUFACTURER IS UNKNOWN AT THIS TIME). THE PATIENT WAS NOT HOSPITALIZED DUE TO THIS EVENT. THE PATIENT RECEIVED A NASOINTESTINAL TUBE SO THAT THE DUODOPA TREATMENT COULD CONTINUE. 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 67 YR Other DUODOPA