BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3180380 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10649
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    September 30, 2012
    Report Date
    May 31, 2013
    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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3986A, LOT# LC0717, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 3986A, LOT# LC0718, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 74002, LOT# N323009, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ¿BULGING OUT¿ AND NEEDED TO BE EVALUATED. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN ABLE TO CHARGE SINCE (B)(6) 2012 AND IS ¿BEYOND FRUSTRATED.¿ IT WAS FURTHER NOTED THE PATIENT HAD NOT EXPERIENCED PAIN RELIEF FOR ¿OVER A YEAR¿ AND WAS ¿FED UP.¿ THE PATIENT JUST WANTED AN INS CHANGE BUT THE EQUIPMENT HAD NOT WORKED SINCE (B)(6) 2012. IT WAS NOTED THE PREVIOUS IMPLANT WAS REPLACED BECAUSE IT WAS ¿RUNNING LOW.¿ IT WAS NOTED THE PREVIOUS IMPLANT LASTED EIGHT YEARS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WANTED TO DISCUSS AN APPOINTMENT AT THE PAIN SPECIALIST WITH THE MANUFACTURING REPRESENTATIVE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281594 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 00056 YR