BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3780972 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08293
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260089 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