BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 3122700 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07993
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 29, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 COULD SEE THEIR ABDOMEN SPASM. THE PATIENT WAS EXPERIENCING A ¿LITTLE BIT¿ OF NAUSEA. THE PATIENT WAS TOLERATING IT LESS AND HAD BEEN USING NAUSEA MEDICATION. THE PATIENT WAS ALSO EXPERIENCING A BURNING SENSATION AT THE DEVICE POCKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT AN ¿INTENSE SHOCKING SENSATION¿ AT THE DEVICE POCKET. IT BEGAN ¿ABOUT ONE AND A HALF MONTHS¿ PRIOR TO THE REPORT AT A FREQUENCY OF ¿ONCE EVERY FEW DAYS.¿ AROUND THE TIME OF THE REPORT THE PATIENT NOTICED IT WAS ¿TWO TO THREE SHOCKS A DAY, SOMETIMES MORE.¿ THE ¿SHOCKS¿ CAUSED HER TO ¿DOUBLE OVER.¿ THE PATIENT STATED THAT HER LAST PROGRAMMING SESSION WAS IN (B)(6) 2012 AND HER HEALTH CARE PROVIDER (HCP) TURNED HER UP TO ¿MAX¿ TO TRY AND IMPROVE HER THERAPY. THE PATIENT¿S THERAPY STILL WORKED BUT NOT ¿QUITE AS GOOD AS IT WAS FOR THE FIRST TWO MONTHS AFTER IMPLANT.¿ THE PATIENT ALSO REPORTED THAT ¿ABOUT TWO MONTHS¿ POST-OPERATIVE HER DEVICE MOVED AROUND ¿QUITE A BIT¿ AND SHE WAS INSTRUCTED TO WEAR A ¿BELLY WRAP¿ TO HELP HOLD IT IN PLACE. THE PATIENT WANTED TO TRY AND COORDINATE A DIAGNOSTIC APPOINTMENT WITH A MANUFACTURER REPRESENTATIVE AT HER CLINIC. 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
    224101 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR