BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4844753 · Received June 15, 2015

    Report

    Report Number
    3004209178-2015-11605
    Event Type
    Injury
    Date Received
    June 15, 2015
    Report Date
    May 27, 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
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (S/N (B)(4)) FOUND NO SIGNIFICANT ANOMALIES AS THE DEVICE WAS OVERDISCHARGED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3888-33, LOT# VA0E60U, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3998, LOT# VA0HXX1, IMPLANTED: (B)(6) 2014-06-05 EXPLANTED: 2015-01-19 PRODUCT TYPE LEAD PRODUCT ID 3888-45 LOT# V994388 SERIAL# IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    UPON FOLLOW UP IT WAS DETERMINED THAT THE EVENT WAS NOT DEVICE RELATED; THE PATIENT HAD ADAPTED TO THE THERAPY. DIAGNOSTIC TESTS THAT WERE PERFORMED INCLUDED X-RAYS WHICH WERE ORDERED BUT NOT DONE, AND AN MRI AFTER EXPLANT. THE PATIENT DID EXPERIENCE A GRADUAL LOSS OF STIMULATION. IF ADDITIONAL INFORMATION IS RECEIVED FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST COVERAGE OVERTIME TO THE LOWER BACK AND LEGS. THE PATIENT WAS NOT IN A CLINICAL STUDY. THE DEVICE WAS NOT REPLACED WITH THE MANUFACTURER¿S PRODUCT. THERE WAS A THERAPY-RELATED ISSUE, FOR THE LOSS OF COVERAGE OVER TIME. THE DEVICE WAS USED WITH/IN THE PATIENT FOR THE INTENDED USE OF TREATMENT. THERE WAS NOT A PATIENT DEATH AND THERE WAS NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELA AFTER THE REMOVAL OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389374 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