BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 3210994 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11446
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN TO THE EMERGENCY ROOM 3 TIMES SINCE (B)(6) 2012 AS WELL AS TO URGENT CARE SEVERAL TIMES BECAUSE HER SYSTEM WAS NOT WORKING. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS WORKING WITH A PHYSICIAN AND HAD AN APPOINTMENT SCHEDULED FOR 2013 (B)(6) TO HAVE THE DEVICE REGULATED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND HAD CONTINUED NAUSEA AND VOMITING THAT HAD ¿NEVER REALLY WENT AWAY.¿ IT WAS STATED, THE IMPEDANCE MEASUREMENTS WERE NORMAL. REPORTEDLY, THE HEALTHCARE PROVIDER REPROGRAMMED THE PATIENT¿S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310886 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR