BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 6135910 · Received November 30, 2016

    Report

    Report Number
    3004209178-2016-24903
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    February 5, 2016
    Report Date
    November 30, 2016
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS REPORTED AS 7-8 MONTHS AGO ((B)(6) 2016). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN AN OVERDISCHARGED STATE. THE PATIENT WASN'T FEELING STIMULATION AND COMMUNICATION WAS UNABLE TO BE ESTABLISHED ON THE PATIENT PROGRAMMER, RECHARGER, OR CLINICIAN PROGRAMMER (B)(4). A PHYSICIAN MODE RESET (PMR) WAS PERFORMED AND THE MANUFACTURER REPRESENTATIVE WAS TO CLEAR THE POWER ON RESET (POR) AS SOON AS THE INS WAS 25% CHARGED. IT WAS REVIEWED THAT THE PATIENT SHOULDN'T ATTEMPT TO TURN THE INS ON OR OFF UNTIL THE POR WAS CLEARED. IT WAS NOTED THAT THE ISSUE STARTED 7-8 MONTHS PRIOR TO THE DATE OF THIS REPORT. ADDITIONAL INFORMATION PROVIDED ON (B)(4) 2016 REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS ABLE TO PULL THE PATIENT¿S INS OUT OF AN OVERDISCHARGE STATE, BUT COULDN'T GET THE DEVICE TO HOLD A CHARGE. FOLLOW UP INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE ON (B)(6) 2016 REPORTED THAT THE PATIENT WAS SCHEDULED FOR REPLACEMENT OF THE DEVICE ON (B)(6) 2016 BUT THE PHYSICIAN CANCELLED THE PROCEDURE DUE TO THE PATIENT BEING SICK. THE INDICATIONS FOR USE FOR THE IMPLANTED DEVICE WERE NOTED AS SPINAL PAIN AND LUMBAR RADICULOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786938 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention