BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3232829 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11934
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S BODY REJECTED THE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED ON (B)(6) 2009. IT WAS NOTED THE THERAPY GAVE THE PATIENT ¿SOME RELIEF FOR A WHILE.¿ THE REPORTER STATED SHE WENT THROUGH A ¿BIG STRUGGLE¿ WITH THE INITIAL IMPLANT AND HER BODY REJECTED THE INS. IT WAS NOTED THE PATIENT GOT AN INFECTION AND PNEUMONIA AND WAS IN THE HOSPITAL FOR 3.5 MONTHS. IT WAS FURTHER NOTED THE PATIENT LOST A ¿GREAT DEAL OF WEIGHT AND WAS VERY WEAK.¿ THE REPORTER STATED SHE DECIDED TO TRY A SECOND INS AND THEIR HEALTHCARE PROVIDER (HCP) ADDED MORE ANTIBIOTICS AND IV FLUIDS. IT WAS NOTED THE SECOND INS WAS NOT REJECTED AND THE PATIENT WAS ABLE TO GET SOME RELIEF FROM GASTROPARESIS SYMPTOMS FOR ABOUT SIX MONTHS FOLLOWING THE IMPLANT OF THE SECOND INS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334159 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Hospitalization| R