BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2780278 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-09066
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    August 1, 2012
    Report Date
    October 4, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION CODE DOES NOT APPLY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3778-45 SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS SCHEDULED TO HAVE LEAD REVISION DUE TO HER LEAD HAD SLIPPED ABOUT 1 MILLIMETER. THE PATIENT WAS ONLY GETTING ABOUT 20% SUCCESSES FROM HER DEVICE. SHE WAS ADVISED TO SPEAK WITH HER DOCTOR REGARDING HER ACTIVITY LEVEL AND HER CONCERNS ABOUT THE LEAD SLIPPING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT THAT REPORTED THAT AROUND 3 MONTHS AFTER PLACEMENT, THE IMPLANTABLE NEUROSTIMULATOR STOPPED HELPING HER PAIN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD A REVISION PERFORMED IN (B)(6) 2012. IT WAS NOTED THAT THE PATIENT ONLY GOT 15 TO 20% PAIN RELIEF. IT WAS NOTED THAT THE PATIENT HAD TRIED EVERYTHING. THE PATIENT WAS NOT FEELING STIMULATION BECAUSE THE DEVICE WAS OFF. THE PATIENT HAD TURNED THE DEVICE OFF FOUR DAYS AGO AND REPORTED THAT THEY DO NOT USE THE THERAPY ALL THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention