BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4891951 · Received July 6, 2015

    Report

    Report Number
    3004209178-2015-12783
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Report Date
    September 26, 2014
    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 PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 74001, LOT# N240169, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID: 3587A, LOT# N0053510, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37092, LOT# 249360004, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 748966, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL DISCOMFORT WITH BURNING AND "ACHY PAIN" AT THE POCKET SITE OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WHICH BEGAN ABOUT TWO MONTHS AGO. THE PATIENT DENIED ANY FALLS OR TRAUMA ASSOCIATED WITH THE ISSUE. IT WAS RECOMMENDED TO THE PATIENT TO CONTACT THEIR PHYSICIAN TO SCHEDULE AN APPOINTMENT TO UNDERGO AN IMPEDANCE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435782 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