BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4826468 · Received June 9, 2015

    Report

    Report Number
    3004209178-2015-10497
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3487A-33, LOT# V192287, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID 3550-39, LOT# N185242, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3986A, LOT# N085459, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SUDDEN LOSS OF STIMULATION AND LESS THAN 50% THERAPY RELIEF (AT THE LEAD LOCATION) FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS). HIGH IMPEDANCES WERE FOUND (>20 ,000 OHMS) ON THE CONTACT (WHICH HELD THE CATHODE THEY WERE USING). THE PATIENT WAS REPROGRAMMED AROUND THE AFFECTED CONTACT WITH THE RESULT THAT THEY HAD THE COVERAGE AGAIN FOR THEIR LEFT LEG AND FOOT WHERE IT WAS DESIRED. THE PATIENT STATUS AT THE TIME OF REPORT WAS NOTED AS "ALIVE - NO INJURY". SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371643 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR