BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 3013344 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03996
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    May 22, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT ON (B)(6) 2013 THE PATIENT BEGAN HAVING PAIN "OUT OF THE BLUE" THAT WAS "ZINGING." IT WAS NOTED THAT THE PATIENT HAD PAINFUL "ZINGS" UNDER HER LEFT LOWER RIBS, AND IT FELT LIKE THE DEVICE HAD BEEN "TURNED UP." IT WAS STATED THAT THE PATIENT WAS SEEN THE WEEK PRIOR TO REPORT FOR AN ADJUSTMENT BECAUSE OF A SUSPECTED END OF BATTERY LIFE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED THAT THE PATIENT FELT THAT ¿SOMETHING MADE THE DEVICE GO UP¿ AND IT WAS ¿ZAPPING¿ HER REALLY BAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THE DEVICE OR THERAPY BUT WAS WORKING WITH HER DOCTOR. THE PATIENT HAD AN APPOINTMENT ON (B)(6)-2013. IT WAS NOTED THAT THE PATIENT WANTED TO TALK TO A MANUFACTURER REPRESENTATIVE.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION OBTAINED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE CAUSE OF THE EVENT WAS THAT THE PATIENT FELT THAT THEY PULLED SOMETHING OR DAMAGED ¿PACER¿ WHEN REACHING FOR AN OBJECT. SPECIFICALLY, IT WAS NOTED THAT THE PATIENT HAD A POSSIBLE MUSCLE STRAIN FROM TWISTING AND BENDING OVER. THE EVENT WAS NOT ATTRIBUTED TO THE DEVICE. IMPEDANCE CHECK ON (B)(6) 2013 SHOWED NORMAL VALUES. REPROGRAMMING WAS PERFORMED ON THE SAME DATE AT WHICH TIME STIMULATIONWAS TURNED DOWN SLIGHTLY. THE CURRENT WAS AT 10.0 MA WITH A PULSE WIDTH RETURNED TO A VALUE OF 330. SYMPTOMS OF PAIN AND A ¿ZINGING¿ FEELING WERE REPORTED. NO HOSPITALIZATION WAS REQUIRE FOR THE EVENT AND THE OUTCOME WAS REPORTED AS NON-SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115917 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1