BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3800427 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08738
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 16, 2014
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT STATED SHE IS NOT GETTING THE PAIN RELIEF AS SHE HAD WITH THE TRIAL AND WAS CONCERNED ABOUT WHAT TO DO FOR PAIN MANAGEMENT. THE STIMULATION WAS FOR HER LOWER BACK. IT WAS STATED THAT STIMULATION WAS INTERMITTENT. THE PATIENT ALSO REPORTED THAT SHE FELT STIMULATION MORE WHEN SHE LEANED BACKWARDS BUT NOT WHEN SHE LEANED FORWARD. THE PATIENT FELT THE STIMULATION SHOULD BE HIGHER. THE PATIENT HAD SHARP PAIN IN HER SPINE WHERE THE LEADS WERE LOCATED. THE PATIENT HAD A FOLLOW UP APPOINTMENT WITH HER PHYSICIAN FOR THE FOLLOWING DAY. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277790 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 00041 YR