BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6967005 · Received October 20, 2017

    Report

    Report Number
    3007934906-2017-00032
    Event Type
    Death
    Date Received
    October 20, 2017
    Date of Event
    August 14, 2017
    Report Date
    February 2, 2018
    Manufacturer
    RESHAPE MEDICAL INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 TO CORRECT PATIENT CODE WHICH WAS INCORRECTLY CODED AS (B)(4) IN FOLLOW UP #1 AND TO ADD ADDITIONAL EVENT INFORMATION.

    Description of Event or Problem · 1

    PATIENT REPORTED ONSET OF BACK PAIN 3.5 WEEKS FOLLOWING BALLOON INSERTION. ON (B)(6) 2017 MD PERFORMED ENDOSCOPY, NOTED PRESENCE OF SIGNIFICANT AMOUNT OF FOOD IN THE STOMACH, REMOVED THE BALLOONS AND NOTED A DISTAL GASTRIC PERFORATION. PERFORATION WAS SURGICALLY REPAIRED AND PATIENT REMAINED HOSPITALIZED FOR APPROXIMATELY 2 WEEKS FOR POST-OP MANAGEMENT AND TREATMENT. ON DAY OF DEATH (WHILE STILL HOSPITALIZED), PATIENT WAS AMBULATORY, NON-FEBRILE, WITH NORMAL HEART RATE AND WHITE BLOOD COUNT BUT THEN EXPERIENCED SUDDEN HEART RATE DROP AND, DESPITE IMMEDIATE MEDICAL INTERVENTION EFFORTS, EXPIRED ON (B)(6) 2017. ICU MD SAID CAUSE OF DEATH WAS A PULMONARY EMBOLISM BY CLINICAL PRESENTATION AND NO AUTOPSY WAS DONE.

    Description of Event or Problem · 1

    FOLLOW UP: PER THE PHYSICIAN, ONE WEEK AFTER THE BALLOON REMOVAL AND PERFORATION REPAIR, THE PATIENT HAD A SUDDEN ONSET OF PAIN WHILE STILL HOSPITALIZED AND THE WHITE BLOOD CELL COUNT WAS ELEVATED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO OBTAIN A CAT SCAN AND ANOTHER GASTRIC LEAK WAS FOUND. THE PATIENT WAS TAKEN TO THE OR. IT WAS DETERMINED THE ORIGINAL REPAIR WAS UNSUCCESSFUL. THE AREA WAS CLEANED OUT, RE-REPAIRED AND DRAINED AGAIN. THE PATIENT CONTINUED TO IMPROVE DAILY WITH A NORMAL WHITE CELL COUNT, AFEBRILE, STABLE VITALS AND TOLERATING LIQUIDS. ON DAY 7 FOLLOWING THE SECOND SURGERY, THE PATIENT HAD A SUDDEN EVENT AND WAS TRANSFERRED TO ICU WHERE TWO HOURS OF RESUSITATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744990 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL INC. 01-0011-001 170515-002 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death| H