BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2820191 · Received November 6, 2012

    Report

    Report Number
    3005099803-2012-05107
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    August 14, 2012
    Report Date
    October 11, 2012
    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 WAS UNABLE TO PROVIDE THE SUSPECT UPN AND DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.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 INITIAL PLACEMENT KIT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6), 2012.ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A DOPAMINERGIC PSYCHOSIS WITH CONFUSION, DUE TO MEDICINE THAT WAS BEING ADMINISTERED, WHICH CAUSED THE PATIENT TO PULL THE DEVICE OUT OF THE STOMA SITE. THE PATIENT WAS HOSPITALIZED FROM (B)(6), 2012. ADMINISTERING OF THE MEDICINE WAS INTERRUPTED AND WAS NOT CONTINUED FOLLOWING TREATMENT.IT WAS REPORTED THAT THE PATIENT HAS FULLY RECOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE INITIAL PLACEMENT KIT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A DOPAMINERGIC PSYCHOSIS WITH CONFUSION, DUE TO MEDICINE THAT WAS BEING ADMINISTERED, WHICH CAUSED THE PATIENT TO PULL THE DEVICE OUT OF THE STOMA SITE. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2012. THE PATIENT ALSO HAD INFLAMMATION AND AN ABSCESS AT THE STOMA SITE. THIS WAS RECTIFIED USING ANTIBIOTICS. ADMINISTERING OF THE MEDICINE WAS INTERRUPTED AND WAS NOT CONTINUED FOLLOWING TREATMENT. IT WAS REPORTED THAT THE PATIENT HAS FULLY RECOVERED.

    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 UNK518

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization SEROPLEX| DUODOPA| NEXIUM| TRANSIPEG| MOTILIUM - ORAL| PARACETAMOL