BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4173391 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19718
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    October 9, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 355024, LOT# N331866, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD 4 REVISIONS IN 2013 BECAUSE THEY FEEL THEIR HEALTH CARE PROVIDER (HCP) DOES NOT KNOW WHAT THEY ARE DOING. THE FIRST REVISION WAS BECAUSE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS POKING 2 INCHES UP OUT OF THEIR SKIN. NO OUTCOME WAS PROVIDED HOWEVER ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654819 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention