BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4808409 · Received June 1, 2015

    Report

    Report Number
    3004209178-2015-09987
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Date of Event
    May 10, 2015
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# V890048, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATOR WAS NOT WORKING. THE PATIENT THOUGHT SHE MAYBE HAD TO RECHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS). SHE FULLY CHARGED IT, THEN TURNED THE STIMULATOR OFF AND BACK ON AGAIN, BUT NOTHING HAPPENED; THE STIMULATOR WAS NOT WORKING. FOLLOW-UP WAS PERFORMED TO DETERMINE IF ANY TROUBLESHOOTING HAD OCCURRED, IF A CAUSE HAD BEEN DETERMINED, IF ANY INTERVENTION OCCURRED, IF THE ISSUE WAS RESOLVED, AND IF THE PATIENT HAD ANY FURTHER CONCERNS. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352446 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 00045 YR