BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 6115113 · Received November 18, 2016

    Report

    Report Number
    3004209178-2016-24387
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    June 1, 2016
    Report Date
    November 22, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS REPORTED AS (B)(6) 2016. SECTION INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID (B)(4), SERIAL# (B)(4 ). PRODUCT TYPE: RECHARGER. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    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

    THE PATIENT REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WAS NOT TAKING CHARGE SINCE TWO MONTHS PRIOR TO THE REPORT. IT WAS ALSO REPORTED THAT THE INSR WOULD NOT CHARGE THE IMPLANT; THE IMPLANT WAS DEPLETED. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT ON (B)(6) 2016 REPORTED THAT THERE WAS A BROKEN CONNECTOR PIN ON THE DESKTOP CHARGER. THE PATIENT MENTIONED THEY HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR LEG SWELLING AND NUMBNESS AND THE INS WAS ¿DEAD¿ BECAUSE THEY COULD NOT CHARGE. THEY ALSO STATED LIKE THERE WERE ¿ANTS IN HER FEET¿. THERE WAS NO OUT OF BOX FAILURE REPORTED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765796 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR