BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2955410 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02521
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 399960, LOT # V990447, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS ADVISED TO SEE HIS DOCTOR TO OBTAIN X-RAYS, AND IT WAS UNCLEAR WHETHER X-RAYS HAD BEEN TAKEN. IT WAS NOTED THAT THE PATIENT WAS GOING TO CONTACT THE MANUFACTURER REPRESENTATIVE AFTER THE X-RAYS WERE DONE; HOWEVER, THE REPRESENTATIVE HAD NOT HEARD FROM OR SEEN THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE HIGH IMPEDANCES ON CONTACTS 4 AND 5. IMPEDANCES WERE GREATER THAN 10,000 OHMS. IT WAS NOTED THE PATIENT WENT TO PHYSICAL THERAPY AND MOVED THEIR NECK AROUND AND AFTERWARDS THEY NOTICED THEY WERE NOT GETTING STIMULATION. THE PATIENT'S LEFT AND RIGHT SIDE WAS PROGRAMMED TOGETHER SO THE PATIENT COULD TURN THEM UP INDIVIDUALLY. IT WAS NOTED THE PATIENT HAD LESS THAN 50% THERAPY RELIEF AND PAIN RETURNED IN THEIR RIGHT SIDE OF THEIR HEAD AND ARM. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58628 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 00043 YR