BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2831695 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10247
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 16, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39286-65, 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 WAS RECEIVING AN OVERSTIMULATION SENSATION. THE PATIENT STATED HIS STIMULATION WAS TOO "STRONG AND POTENT" AND PRIOR TO (B)(6) 2012 THE PATIENT FELT A "JOLTING SENSATION". ON (B)(6) 2012 THE PATIENT STAYED OVERNIGHT IN THE HOSPITAL DUE TO A BOWEL BLOCKAGE WITH SEVERE STOMACH PAIN, WHICH WAS CLEARED UP. THE PATIENT STATED HIS STIMULATION WORKED "A LITTLE BETTER" THE MORNING OF THE REPORT, BUT WAS STILL "A LITTLE HIGH" FOR HIM. THE PATIENT WAS ASSISTED IN ADJUSTING HIS ADAPTIVE STIMULATION, WHICH HE STATED "FELT BETTER".

    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