BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3770054 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08040
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) EXPERIENCED ITS CONFIRMED THIRD OVERDISCHARGE. IT WAS FURTHER REPORTED THE INS HAD REACHED END OF SERVICE (EOS) AT THAT TIME. IT WAS STATED THE PATIENT HAD NOT RECHARGED THE INS ENOUGH. IT WAS NOTED THE INS WAS SUCCESSFULLY RESET BY A PHYSICIAN MODE RECHARGE (PMR) AT THE TIME OF REPORT. IT WAS ADDITIONALLY NOTED THAT REPLACEMENT OF THE INS WOULD BE REQUIRED AS A RESULT OF THE EVENT. IT WAS STATED THE INS REMAINED IMPLANTED AND OUT OF SERVICE AT THE TIME OF REPORT. IT WAS REPORTED THE PATIENT EXPERIENCED ¿NO¿ SYMPTOMS OR COMPLICATIONS AND WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. ANALYSIS OF THE INS DATA RECORDS CONFIRMED THE OVERDISCHARGE WAS THE PATIENT¿S THIRD. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248403 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 00057 YR