BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4221947 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20878
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 13, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3888-33, LOT# VA06MG2, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# VA06MG2, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ¿HAD BEEN HURTING REAL BAD¿ IN THE PRIOR WEEK AND THAT IT WAS ¿PROBABLY THE WORSE¿ ON THE DAY OF THE REPORT. THE PATIENT NOTED SHOOTING PAIN DOWN HER LEG THAT WAS ¿PRETTY INTENSE¿ ON THE DAY OF THE REPORT AND SHE COULD HARDLY WALK. IT WAS NOTED THAT THE PATIENT HAD ALREADY INCREASED IT WITH HER PATIENT PROGRAMMER AND ¿IT WAS NOT HELPING.¿ IT WAS NOTED THAT THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND THAT THE STIMULATION HAD NOT BEEN WORKING OR COVERING THE PATIENT¿S PAIN IN THE PRIOR TWO WEEKS. IT WAS NOTED THAT THE PATIENT RECEIVED A STEROID SHOT ON (B)(6) 2014 WHICH SAVED THE PATIENT AS THE PATIENT WAS PAIN FREE FOR THE FIRST TIME IN TWO WEEKS. IT WAS NOTED THAT THE STEROID SHOT HELPED HER PAIN SYMPTOMS SOME. IT WAS REPORTED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. FOR THE PAST WEEK, THE PATIENT WOULD JUST BE SITTING STILL AND SHE WOULD FEEL A JOLT SENSATION. IT WAS NOTED THAT THE PATIENT HAD NOT HAD ANY TRAUMA/FALLS RECENTLY. IT WAS NOTED THAT THE PATIENT NO LONGER HAD ACCESS TO ONE OF HER PROGRAMS ON THE PATIENT PROGRAMMER. THE PATIENT NOTED THAT SHE HAD 4 PROGRAMS BUT ONLY 3 PROGRAMS WERE SHOWING ACTIVE ON HER PATIENT PROGRAMMER FOR THE PAST WEEK. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN BY THE MANUFACTURING REPRESENTATIVE. AN IMPEDANCE CHECK WAS PERFORMED AND THE PATIENT¿S STIMULATOR WAS WORKING PROPERLY EXCEPT FOR ONE ELECTRODE THAT HAD HIGH IMPEDANCES. THIS WAS THE SAME ELECTRODE THAT WAS BEING STIMULATED. AFTER REPROGRAMMING AND MOVING THE STIMULATION AWAY FROM THAT ELECTRODE, THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND IT WAS COVERING THE PATIENT¿S PAIN WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701350 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 00054 YR