BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3051063 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05892
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 25, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL ABOUT 2 WEEKS PRIOR TO THE REPORT AND HIT HER BUTTOCK AROUND WHERE THE STIMULATOR WAS IMPLANTED. THE PATIENT HAD TO TURN STIMULATION UP HIGHER SINCE THE FALL TO FEEL IT AND ALSO NOTED A LACK OF THERAPEUTIC EFFECT. THE PATIENT FELT LIKE THE STIMULATOR HAD MOVED. THE PATIENT HAD TO CHARGE MORE OFTEN AFTER THE FALL; AT LEAST 2-3 TIMES A WEEK. THE PATIENT HAD CHARGED 2 DAYS PRIOR AND THE STIMULATOR WAS NOTED TO BE HALF FULL. THE PATIENT WAS REDIRECTED TO HER PHYSICIAN. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED A LOSS OF THERAPEUTIC EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148272 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