BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3922214 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12702
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 16, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-39, LOT# N350849, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 3776-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3776-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NOTICED ONE DAY PRIOR TO REPORT THEY WERE UNABLE TO CONNECT TO THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) OR PATIENT PROGRAMMER. IT WAS NOTED THAT IT HAS BEEN 4 WEEKS OR LONGER SINCE THE PATIENT LAST CHARGED. IT WAS REPORTED TWO WEEKS PRIOR TO REPORT THE PATIENT HAD AN EPIDURAL AND ¿HAD IT CLOSE TO DISCHARGER¿ AND THEY TURNED THE INS OFF AND IS NOW UNABLE TO RECHARGE. IT WAS NOTED THERE WAS A COUPLING PROBLEM AND THE DEVICE WAS SUSPECTED TO BE IN OVER-DISCHARGE. IT WAS NOTED THAT PATIENT COMPLIANCE WAS THE PRIMARY REASON FOR THE OVER-DISCHARGE. IT WAS FURTHER REPORTED THAT AFTER THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS RECOVERED FROM OVER-DISCHARGE THE PATIENT EXPERIENCED A SUDDEN OVERSTIMULATION SENSATION DURING THEIR RECHARGE SESSION. IT WAS NOTED ON (B)(6) 2014 THE PATIENT ADDRESSED THE OVER-DISCHARGE AND WENT HOME TO CHARGE WITH ACTIVE POWER ON RESET (POR) AND GOT THE OVERSTIMULATION SENSATION WHILE WORKING WITH THEIR CHARGER. IT WAS NOTED A PHYSICIAN MODE RESET (PMR) WAS INITIATED WITH THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) AND ¿THIS ADDRESSED THE OVERSTIMULATION SENSATION¿. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS GREATER THAN 50% THERAPY REDUCTION DUE TO THE OVER-DISCHARGE. IT WAS NOTED THE OVER-DISCHARGE WAS CONFIRMED AND A SUCCESSFUL CHARGE WAS NOTED ON (B)(6) 2014. IT WAS NOTED THE REASON FOR THE OVER-DISCHARGE WAS BECAUSE THE PATIENT HAD AN INJECTION AND TURNED THEIR DEVICE OFF TO EVALUATE THE EFFECTIVENESS OF THE INJECTION AND DID NOT CHARGE DURING THAT PERIOD OF TIME. IT WAS NOTED WHEN THE DEVICE WAS OVER-DISCHARGED THE PATIENT EXPERIENCED A LACK OF THERAPY. IT WAS FURTHER NOTED THE PATIENT EXPERIENCED STRONG SHOCKING SENSATIONS THAT THEY WERE UNABLE TO TURN OFF. IT WAS NOTED THAT NO REPROGRAMMING WAS NEEDED BUT A POWER ON RESET (POR) WAS CLEARED WITH THE CLINICIAN PROGRAMMER. LASTLY, IT WAS REPORTED THE PATIENT IS NOW RECEIVING EFFECTIVE THERAPY AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400472 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