BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3122928 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-08011
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 399960, LOT# V608681, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 399960, LOT# V608681, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ALLEGORIC REACTION TO THE IMPLANT AND THE LEADS. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED UNDER THE BREAST OF THE PATIENT¿S RIGHT SIDE. IT WAS FURTHER NOTED THAT THE LEADS WENT TO THE LEFT SIDE OF THE PATIENT¿S HEAD. IT WAS NOTED THAT THE LEFT SIDE OF THE PATIENT¿S HEAD ¿COULD NOT BE TOUCHED DUE TO PAIN CAUSED BY THE INS.¿ IT WAS NOTED THAT THE PATIENT¿S INS WAS ¿PROTRUDING OUT,¿ CAUSING TERRIBLE PAIN. IT WAS NOTED THAT ¿AT ONE TIME, THE PATIENT WAS PARALYZED AND COULD NOT MOVE.¿ IT WAS NOTED THAT THE PAIN OCCURRED WHILE THE IMPLANT WAS TURNED ON AND OFF. IT WAS NOTED THAT THE INS AND LEADS WERE REMOVED ON (B)(6) 2013. IT WAS NOTED THAT THE SKULL BONE FROM THE LOCATION OF THE LEADS WAS REMOVED. IT WAS NOTED THAT THE HEALTH CARE PROVIDER ¿INITIALLY THOUGHT IT WAS SURGICAL ISSUES, BUT THEN REALIZED THE PATIENT WAS HAVING AN ALLERGIC REACTION.¿ IT WAS NOTED THAT THE PATIENT ¿STILL WAS NOT FEELING RIGHT AND SHE WAS HEALING.¿ ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED IN (B)(6) 2013 DUE TO THEIR BODY REJECTING IT. IT WAS ALSO NOTED THAT THEY HAD AN APPOINTMENT IN (B)(6) 2013. THE PATIENT STILL HAD CONCERNS BECAUSE THE SITE WHERE THE BATTERY WAS HAD NOT HEALED. IT WAS ALSO REPORTED THAT THE PATIENT GOT A COLD WHILE IN THE HOSPITAL AND HAD TO GO BACK INTO THE HOSPITAL IN (B)(6) 2013 FOR PNEUMONIA. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223657 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R