BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4092867 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17086
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS OVERDISCHARGED. THIS WAS THE PATIENT¿S THIRD INS OVERDISCHARGE. THE PATIENT HAD MET WITH A MANUFACTURING REPRESENTATIVE AND A PHYSICIAN MODE RECHARGE (PMR) WAS DONE. WHEN THE MANUFACTURING REPRESENTATIVE WAS ABLE TO COMMUNICATE WITH THE INS THEY GOT A POWER ON RESET (POR) MESSAGE. ONCE THE POR MESSAGE WAS CLEARED, AN END OF SERVICE (EOS) SCREEN WAS DISPLAYED ON THE PATIENT PROGRAMMER. THE PATIENT HAD STIMULATION OFF SINCE (B)(6) 2014 DUE TO OTHER MEDICAL ISSUES. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT AND THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. NO SYMPTOMS, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571399 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