BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2924099 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00795
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 2, 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

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION WHENEVER A HARLEY DAVIDSON MOTORCYCLE DROVE BY OUTSIDE. THE PATIENT ALSO EXPERIENCED THIS WHEN HE USED HIS MICROWAVE AS WELL AS WHEN HE WENT TO THE STORE. THE REPORTER STATED THAT THE PATIENT WAS NOT USING HIS STIMULATION 'TOO MUCH' AND WAS STILL ON PAIN MEDICATION. IMPEDANCES WERE REPORTED TO BE NORMAL; BETWEEN 900 OHMS AND 1100 OHMS. REPROGRAMMING WAS ALSO DONE. THE PATIENT'S THERAPY WAS WORKING NORMALLY OTHERWISE. ADDITIONAL INFORMATION RECEIVED 5 DAYS LATER INDICATED THAT THERE WERE NO MALFUNCTIONS SEEN OR CAUSE OF ISSUE DETERMINED. THERE WERE NO INTERVENTIONS TAKEN OR PLANNED. PATIENT OUTCOME WAS GOING TO BE AVAILABLE IN 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29643 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