BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 7681713 · Received July 12, 2018

    Report

    Report Number
    3004209178-2018-15595
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    June 11, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    UDI-DI
    00643169614246
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 4351-35 LOT# (B)(4).(B)(6)2018 EXPLANTED: PRODUCT TYPE LEAD MEDTRONIC, INC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 4351-35, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. PRODUCT ID: 4351-35, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HCP VIA A REP. IT WAS REPORTED THAT THE REP AND HCP SAW THE PATIENT ON (B)(6)2018 AND THE PATIENT TOLD THEM THEY WERE FEELING GREAT AND THEIR DEVICE WAS HELPING THEM GAIN WEIGHT. THEY BELIEVED THE SHOCKING ONLY OCCURRED DURING THEIR MENSTRUAL CYCLE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INTENSE SHOCKING FROM THEIR STIMULATOR SINCE THEIR SURGERY ON (B)(6) 2018. THE INTENSITY AND DURATION HAD INCREASED, ACCORDING TO THE PATIENT, AND A FOLLOW-UP APPOINTMENT WAS SCHEDULED FOR (B)(6) 2018 WITH THEIR HCP. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525854 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 37800 00643169614246

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR