BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MEDTRONIC ADVANCED ENERGY DEVICE

    MDR report key: 2704064 · Received August 10, 2012

    Report

    Report Number
    1226420-2012-00036
    Event Type
    Injury
    Date Received
    August 10, 2012
    Date of Event
    December 21, 2011
    Report Date
    July 16, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE ADVERSE EVENT SPECIFICS WERE GIVEN FOR THREE SEPARATE PATIENTS THE MATCHING OF THE PATIENT NUMBER WITH THE ADVERSE EVENT SPECIFICS IS UNABLE TO BE MADE VIA THE PUBLISHED LITERATURE THEREFORE THIS ADVERSE EVENT WILL BE REPORTED AS ONE MDR. ARTICLE REFERENCE: BLANSFIELD, J. ET. AL (2011). NOVEL METHOD OF STUMP CLOSURE FOR DISTAL PANCREATECTOMY WITH A 75% REDUCTION IN PANCREATIC FISTULA RATE. JOURNAL OF GASTROINTESTINAL SURGERY, 16, 524-528. DOI 10.1007/S11605-011-1794-1.

    Description of Event or Problem · 1

    ARTICLE PUBLISHED ONLINE 12/21/2011 INDICATING THREE PATIENTS TREATED WITH MEDTRONIC ADVANCED ENERGY PRODUCTS (PRODUCT UNSPECIFIED) DEVELOPED PANCREATIC FISTULAS SUBSEQUENT TO DISTAL PANCREATECTOMY (DP) PROCEDURES PERFORMED. ONE PATIENT HAD A GRADE A PANCREATIC FISTULA, TWO PATIENTS HAD GRADE B PANCREATIC FISTULAS. ONE PATIENT HAD LOW OUTPUT, HIGH AMYLASE DRAINAGE FROM OPERATIVELY PLACE DRAIN REMOVED 2 WEEKS POST-OP, ONE PATIENT HAD LOW OUTPUT, HIGH AMYLASE DRAINAGE FROM OPERATIVELY PLACED DRAIN REMOVED 5 WEEKS POST-OP, AND THE THIRD PATIENT HAD THE OPERATIVELY PLACED DRAIN REMOVED AND SUBSEQUENTLY REQUIRED AN INTERVENTIONAL RADIOLOGY PLACED DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MEDTRONIC ADVANCED ENERGY DEVICE UNKNOWN MEDTRONIC ADVANCED ENERGY DEVICE GEI MEDTRONIC ADVANCED ENERGY UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other