BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2801225 · Received October 23, 2012

    Report

    Report Number
    3004209178-2012-09436
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID, 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT FELT STIMULATION AND IT FELT LIKE SHE WAS BEING "ELECTROCUTED." THE PATIENT FELT SHOCKS THAT TRAVELED FROM THE DEVICE POCKET ACROSS THE BODY AND UP, AND IT WOULD LAST FOR A WHILE. THE STIMULATOR WAS TURNED DOWN SEVERAL MONTHS PRIOR TO REPORT DUE TO THE SENSATION. THE DEVICE WAS REQUESTED TO BE TURNED OFF AS THE PATIENT WAS NOT COMFORTABLE WITH THE SENSATION AND SHE DID NOT FEEL THAT THE DEVICE HELPED HER VERY MUCH. SYMPTOMS WERE GOING TO BE MONITORED FOLLOWING TURNING OFF THE DEVICE. IT WAS NOTED, THE PATIENT WAS VERY THIN. SETTINGS WERE REPORTED TO BE WITHIN NORMAL RANGE. FOLLOW UP WAS PLANNED FOR ABOUT A MONTH LATER. APPROXIMATELY ONE WEEK LATER IT WAS REPORTED THAT WITH THE DEVICE OFF, THE PATIENT'S SYMPTOMS OF NAUSEA AND VOMITING HAD RETURNED. THE PATIENT WAS HOSPITALIZED FOR THE PRIOR FEW DAYS. THE HEALTH CARE PROVIDER WAS GOING TO SCHEDULE THE PATIENT FOR AN APPOINTMENT TO TURN THE STIMULATOR BACK ON. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization