BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3170612 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10398
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    April 23, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37744 SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 355531 LOT# N347326; PRODUCT TYPE SCREENING DEVICE PRODUCT ID 365538 LOT# N333148 IMPLANTED: 2012 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER IMPLANT THE REPRESENTATIVE WORKED ON REPROGRAMMING TWICE. THE PATIENT STATED THAT AFTER THE SECOND REPROGRAMMING SESSION, SHE STARTED TO HAVE TROUBLE. THE PATIENT REPORTED THAT WHEN SHE CHANGED POSITIONS, THERAPY SURGED FROM 3.5 VOLTS TO 6. SURGING ALSO OCCURRED WHEN THE PATIENT CHANGED FROM SITTING TO STANDING. THERE WAS NO SPECIFIC TIMEFRAME FOR THIS ISSUE. THE PATIENT ADJUSTED THE SETTING TO 3.5 VOLTS FOR ALL THE PROGRAMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE STIMULATION WENT UP IT HURT THE PATIENT A LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A ¿SHOOTING SENSATION.¿ THE PATIENT STATED THAT WHEN SHE SITS ON THE TOILET OR IS WALKING, SHE FEELS THE STIMULATION SHOOT UP HER BACK ¿LIKE THE STIMULATION LEVEL INCREASES.¿ THE PATIENT NOTED THAT THIS OCCURS RANDOMLY AND DOESN¿T OCCUR EVERY TIME SHE GETS INTO THOSE POSITIONS, BUT LATELY IT HAD OCCURRED EVERY TIME SHE SAT ON THE TOILET. THE SYMPTOMS BEGAN ABOUT TWO WEEKS AGO. THE PATIENT HAD THE ADAPTIVE STIMULATION FEATURE ACTIVE, AND WHEN SHE FELT THE SHOOTING SENSATION, THE PATIENT TURNED DOWN STIMULATION WHICH HELPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271347 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