BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 5278448 · Received December 9, 2015

    Report

    Report Number
    3004209178-2015-24081
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    October 1, 2015
    Report Date
    November 12, 2015
    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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PREVIOUSLY REPORTED (B)(4) WAS FOUND TO NOT APPLY UPON FURTHER EVALUATION OF THE EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8591-38, LOT# D17878, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3550-39, LOT# N334554, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 355531, LOT# N340428, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED A CHANGE IN THERAPY. THE PATIENT WAS "GETTING THESE ELECTRIC SHOCKS IN MY BACK AND NECK." THE PATIENT STATED THAT "IT'S RIGHT WHERE THE STIMULATOR IS" AND NOTED THAT THE SHOCKS "ARE PRETTY INTENSE" AND "THE STIMULATOR ISN'T EVEN ON WHEN IT HAPPENS." THE PATIENT HAD FALLEN AT WORK IN (B)(6), BUT DID NOT BELIEVE THIS HAD ANYTHING TO DO WITH THE SHOCKING SENSATION BEING FELT NOW. THE PATIENT INDICATION INCLUDED NON-MALIGNANT PAIN, AND FAILED BACK SURGERY SYNDROME. FOLLOW-UP WAS PERFORMED TO DETERMINE WHAT LEAD TO THIS OCCURRING, AND WHAT STEPS WERE TAKEN TO RESOLVE THE REPORTED EVENT. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813958 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 00054 YR