BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2961486 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02630
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 27, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACK PAINS AND LEG CRAMPS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR "HEART/LUNG AND PAIN ISSUES" AND WAS DISCHARGED ONE WEEK PRIOR TO REPORT. DURING THEIR STAY, THE PATIENT WAS ADMINISTERED "PAIN INJECTIONS AND ORAL MEDICATION" FOR TREATMENT OF THEIR PAIN. THE PATIENT REPORTED EXPERIENCING "SLAMMING" IN THEIR BACK NEAR THE DEVICE AND HAVING EXPERIENCED "HORRIFIC CRAMPS DOWN LEGS" WHILE LYING DOWN. THE PATIENT REPORTED THAT THEIR PRESCRIBED CRAMPING MEDICATION "HADN'T HELPED" AND SHE WAS "UP ALL NIGHT." UPON TURNING THE STIMULATION OFF, THE PATIENT REPORTED THAT THE "SLAMMING STOPPED, BUT NOT THE PAIN." THE PATIENT REPORTED THAT THEY WERE STILL IN PAIN, BUT SHE WAS WORKING WITH HER DOCTOR OR MANUFACTURE REPRESENTATIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65168 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 Required Intervention