BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTAD COMPACT LEAD

    MDR report key: 2833377 · Received November 15, 2012

    Report

    Report Number
    6000153-2012-00223
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 17, 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 RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD PACKAGING FOUND THAT THE LEAD WAS PACKAGED INCORRECTLY, RESULTING IN THE LID TO NOT HAVE A PROPER SEAL. THE PRODUCT STUCK OUT OF PACKAGING WHERE THERE WAS NO ADHESIVE. SEAL WAS INTACT ALONG THE REST OF THE PACKAGING.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS NOTICED THAT IN THE PACKAGE OF THE LEAD COMPONENT, THE SPRING WIRE APPEARED TO HAVE SLIPPED OUT OF PLACE AND WAS LAYING UP ON THE EDGE OF THE INNER PACKAGE WHEN THE TYVEK COVER WAS SEALED IN PLACE. THE LEAD WAS SET ASIDE AND NOT USED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTAD COMPACT LEAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 3778 V803533033

    Patients

    Seq Age Sex Outcome Treatment
    1