BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2801906 · Received October 23, 2012

    Report

    Report Number
    6000153-2012-00215
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS OF THE LEAD FOUND NO ANOMALY. ANALYSIS OF THE STYLET FOUND NO SIGNIFICANT ANOMALY. THE STYLET WIRE WAS BENT, NO ISSUES WERE FOUND REGARDING REMOVING OR FULLY REINSERTING THE STYLET INTO THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD STYLET WOULD NOT FULLY SEAT INTRAOPERATIVELY. A NEW LEAD WAS USED. PATIENT STATUS AT TIME OF REPORT WAS NOTED AS 'NO INJURY/NO ADVERSE EVENT.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 3778-60

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR