BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3150459 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08732
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 16, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A LOT OF PAIN IN THE AREA WHERE THE STIMULATOR WAS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A POWER-ON-RESET CONDITION ON THE DAY OF THE REPORT WITH AN UNKNOWN ERROR CODE. ADDITIONAL INFORMATION RECEIVED FIVE DAYS LATER REPORTED THAT THERE WAS A POR CONDITION. IT WAS STATED THAT THERE WAS AN ERROR CODE OF 0400 AND THIS WAS THE PATIENT'S 3RD POR. IT WAS NOTED THAT ON (B)(6) 2013, THE PATIENT ALSO HAD A POR CONDITION AND LOST STIMULATION. IT WAS STATED THAT THE PATIENT HAS BEEN HAVING RADIATION TREATMENT AND LAST RATION SESSION WAS ON (B)(6) 2013. IT WAS STATED THAT A POR CONDITION WAS NOT SURPRISING BECAUSE THE STIMULATOR WAS EXPOSED TO SCATTER RADIATION. ADDITIONALLY IT WAS NOTED THAT THE POR WAS CLEARED AND STIMULATION WAS BACK. THE PATIENT HAD BEEN HAVING RADIATION FOR THE PAST 6 WEEKS. WHICH LIKELY CAUSED THE "RESETS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250713 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 00052 YR