BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3903261 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12304
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), PRODUCT TYPE: LEAD; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3887-56, LOT# V287549, PRODUCT TYPE: LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3550-39, LOT# N343243, PRODUCT TYPE: ACCESSORY; PRODUCT ID 3887-56, LOT# V287549, PRODUCT TYPE: LEAD; PRODUCT ID 3550-39, LOT# N328318, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM (ER) WHERE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN ¿FIRING NON-STOP SINCE 1230¿ AND THE ISSUE CONTINUED TO THE TIME OF REPORT OF 1710. IT WAS NOTED THAT WITH EACH PULSE FROM THEIR INS CAUSED THE PATIENT¿S MUSCLES TO CONTRACT AND TWITCH. THE PATIENT WAS ALSO REPORTED TO BE PALE, DIAPHORETIC, AND HAD A HARD TIME FINDING THE STRENGTH TO ¿EVEN SPEAK IN FULL SENTENCES¿. IN ADDITION, THE PATIENT APPEARED TO BE GOING INTO RHABDOMYOLYSIS AND ¿WAS GETTING WORSE¿. INITIALLY, THE FIRST MANUFACTURER¿S REPRESENTATIVE CONTACTED NOTED THAT THE ¿UNITS BATTERY SHOULDN¿T LAST THAT LONG¿ AND THAT THE INS WAS NOT CAUSING THE PATIENT¿S ISSUES (DID NOT SEE THE PATIENT). IT WAS NOTED THAT ANOTHER REPRESENTATIVE WAS THEN CONTACTED. FOLLOW UP INFORMATION RECEIVED ON JUNE 26, 2014 REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE MET WITH THE PATIENT. IT WAS NOTED THAT THE PATIENT HAD BEEN AT THEIR HEALTHCARE PROFESSIONAL¿S (HCP) OFFICE EARLIER IN THE DAY AND WAS SHOWN HOW TO USE THE PROGRAMMER UNIT BUT ONCE THEY GOT HOME THEY STARTED ¿PRESSING BUTTONS IN UNKNOWN SEQUENCE¿ WHICH LED TO THE DEVICE SHOCKING THEM. IT WAS REPORTED THAT THE DEVICE WAS DOING SOME ¿A SELF TEST OF SOME KIND¿. THE PATIENT WAS REPROGRAMMED AND DISCHARGED FROM THE ER TO HOME AFTER A FEW HOURS OF OBSERVATIONS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381053 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 00051 YR