BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 776378 · Received September 8, 2006

    Report

    Report Number
    2029203-2006-00631
    Event Type
    Malfunction
    Date Received
    September 8, 2006
    Date of Event
    August 29, 2006
    Report Date
    September 8, 2006
    Manufacturer
    ADVANCED BIONIS CORPORATION
    Product Code
    LGW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED CHARGING ISSUES BETWEEN THE IMPLANT AND THE EXTERNAL EQUIPMENT SHORTLY AFTER IMPLANT. AN ADVANCED BIONICS REPRESENTATIVE PERFORMED DEVICE EVALUATION. THE PROBLEM WAS CONFIRMED. THE PATIENT WILL BE IMPLANTED WITH A NEW ADVANCED BIONICS SPINAL CORD STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW ADVANCED BIONIS CORPORATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN