BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4259140 · Received November 18, 2014

    Report

    Report Number
    3004209178-2014-21794
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    August 1, 2014
    Report Date
    October 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3587A25, LOT# N231018, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WIRE IN THE PATIENT¿S FACE FROM THE LEFT SIDE (OCCIPITAL NERVE STIMULATOR) MOVED IN (B)(6) OR (B)(6) 2014. THE PATIENT¿S WIRES WERE MOVED SURGICALLY TO CORRECT THE ISSUE ON (B)(6) 2014. THE PATIENT REPORTED THAT THERE WAS A DEEP DIMPLE IN HER FACE FROM THE LEAD WIRE. REFER TO MANUFACTURER REPORT NUMBER 3004209178-2014-21790.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744075 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 00068 YR Required Intervention