BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 3122163 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07970
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 30, 2013
    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
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ACUTE PAIN ON THE ¿UPPER LEFT-HAND CORNER¿ OF THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE. THE REPORTER INDICATED THAT THIS STARTED ¿A WHILE AGO, FOR ABOUT A YEAR NOW¿. THE REPORTER INDICATED THAT X-RAYS WERE TAKEN AND THE LEADS REPORTEDLY LOOKED ¿TOTALLY INTERTWINED¿. ADDITIONALLY, TWO LEADS WERE ¿BROKEN AND LOOSE¿. IT WAS NOTED THAT THE PATIENT¿S LEADS WERE NOT ¿VERY GOOD AT ALL¿ AND WERE A ¿MESS¿. THE REPORTER STATED THAT ¿THERE WAS A WIRE MUMBO-JUMBO GOING ON RIGHT NOW¿. IT WAS NOTED THAT THE PATIENT ¿MAY PURSUE¿ HAVING HER SYSTEM REMOVED.

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED THE PATIENT EXPERIENCED NAUSEA AND IT WAS ¿NOT VERY WELL CONTROLLED AT ALL.¿ IT WAS ALSO NOTED THE PATIENT WAS "NOT SO HOT RIGHT NOW." THE PATIENT WAS IN THE HOSPITAL FOR A DAY, A WEEK PRIOR TO THIS REPORT, AND THE CHEST X-RAYS WERE TAKEN AT THAT TIME. IT WAS ALSO PREVIOUSLY REPORTED THE PATIENT STILL HAD HER PRIOR IMPLANTED PULSE GENERATOR (IPG) AND LEADS IMPLANTED AND INACTIVE ON THE RIGHT SIDE OF HER BODY AND HER CURRENT IPG WAS IMPLANTED ON THE LEFT SIDE OF THE BODY. IT WAS UNCLEAR WHICH LEADS WERE INTERTWINED AND ¿BROKEN AND LOOSE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224874 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization