BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 4092906 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17089
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 20, 2014
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WENT THROUGH A METAL DETECTOR AND GOT A JOLT. THE PATIENT STATED THEY HAD TO GO TO THEIR DOCTOR AND HAVE THEIR BATTERY REPLACED. IT WAS NOTED THE PATIENT WENT THROUGH THE SECURITY IN COURT AROUND FEBRUARY OR MARCH AND ABOUT A MONTH AFTERWARD HAD THE SURGERY TO REPLACE THEIR GASTRIC STIMULATOR. AFTER THE PATIENT GOT THE JOLT THEY STARTED GETTING THEIR SYMPTOMS BACK BECAUSE THEIR ¿BATTERY WAS GONE.¿ THE PATIENT STATED "IF IN FACT HER GOING THROUGH METAL DETECTOR AND HAVING THE LEAD INSIDE AND THIS STUFF IS MESSING UP INSIDE OF MY BODY CAN BRING FORTH SOME KIND OF PROBLEMS." ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER STATED THE CAUSE OF THE EVENT WAS METAL DETECTOR INTERFERENCE WITH THEIR DEVICE. THE METAL DETECTOR GAVE THE PATIENT A SHOCK. IT WAS STATED THERE WERE NO ACTIONS TAKEN TO RESOLVE THE ISSUE AND THE CAUSE OF THE EVENT WAS NOT DEVICE RELATED. THE HEALTHCARE PROVIDER STATED THE DEVICE WAS DAMAGED BUT THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT AND THEY WERE HAPPY WITH THEIR THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573546 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention