BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2760856 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-08554
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-75, SERIAL # (B)(4), PRODUCT TYPE LEAD. PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. PRODUCT ID 3708120, SERIAL # (B)(4), PRODUCT TYPE EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIS DEVICE "IN AND OUT" THREE TIMES. ONCE IT WAS DONE "RIGHT" AND TWICE IT WAS DONE "WRONG." THE THIRD TIME IT NEEDED TO BE "REPLACED" AND WAS TOO FAR LEFT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTH CARE PROVIDER (HCP) HAD NOT SEEN THE PATIENT SINCE (B)(6)-2012. THE HCP COULD NOT ANSWER ANY QUESTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention