BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2863831 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11333
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 15, 2012
    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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE THE IMPLANT, THE PATIENT EXPERIENCED SCIATICA WHEN HE TURNED HIS AMPLITUDE UP. IT WAS STATED THAT THE DEVICE "ELECTROCUTED" THE PATIENT WHEN HE LIED DOWN, CAUSING HIS JAW TO "CLENCH." THERE WERE NO FALLS OR TRAUMA. IT WAS LATER REPORTED THAT THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT TO SET UP ADAPTIVE STIMULATION ON (B)(6) 2012. IT WAS NOTED THAT THE PATIENT WAS INSTRUCTED TO TURN DOWN THE STIMULATION WHEN THE PATIENT WENT TO LIE DOWN. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD ADAPTIVESTIM SET UP. IT WAS STATED THAT THE PATIENT WAS "MUCH HAPPIER" NOW. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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