BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3032806 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04528
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 18, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS NO STIMULATION SENSATION AND A SURGING SENSATION. THE PATIENT HAD NOTICED THREE WEEKS PRIOR THAT THEIR DEVICE WAS "CUTTING OFF RANDOMLY." IT WAS NOTED, THE PATIENT'S DEVICE SHUT OFF "FOR BETWEEN 2-6 MINUTES 8 TIMES IN A 1.5 HOUR PERIOD." IT WAS NOTED, THE PATIENT HAD ADAPTIVE STIMULATION SET PRIOR TO THIS. WHEN THE PATIENT COUGHED THE STIMULATION "SURGED" AND THEY COULD FEEL THE STIMULATION IN THEIR FOOT. STIMULATION WAS ALSO NOTICEABLE WHEN THE PATIENT WOULD PUT THEIR SHOULDERS BACK. IF THE PATIENT WALKED THE LENGTH OF THEIR HOME THREE TIMES IT WOULD OCCUR. IT WAS NOTED THE PATIENT HAD NOT BEEN ABLE TO CHECK THEIR IMPLANT WITH THEIR PROGRAMMER WHEN IT HAPPENED BUT THEY DID NOTE WHEN IT OCCURRED THEIR STIMULATION HAD GONE FROM 5.9 VOLTS TO 3.4 VOLTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT GET ANY IMAGES ON THE SCREEN EXCEPT THE QUESTION MARK SCREEN. THE PATIENT WAS REALLY FRUSTRATED. IT WAS REPORTED THAT THE PATIENT HURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136098 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