BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCS LEAD

    MDR report key: 2366469 · Received December 12, 2011

    Report

    Report Number
    3007566237-2011-09215
    Event Type
    Malfunction
    Date Received
    December 12, 2011
    Date of Event
    November 21, 2011
    Report Date
    November 21, 2011
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE INITIAL MDR WAS FILED AS MFR REPORT # 3007566237-2011-09215. ADDITIONAL REVIEW INDICATED THE CORRECT MANUFACTURING SITE WAS SITE (B)(4). ANALYSIS OF LEAD MODEL 3877-45, LOT # V820540 DETERMINED THE STYLET COIL WAS PERFORATED BY THE STYLET. ANALYSIS OF STYLET ACCESSORY MODEL UNK LOT # UNK DETERMINED NO ANOMALY WAS FOUND.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE NEUROSTIMULATOR IMPLANT PROCEDURE, IT WAS NOT POSSIBLE TO INSERT THE LEAD GUIDE WIRE "WELL" INTO THE LEAD. IMPEDANCE READINGS WERE LESS THAN 50 OHMS ON LEAD ELECTRODE #0, AND GREATER THAN 10,000 OHMS ON LEAD ELECTRODE # 7. THE LEAD WAS NOT USED IN THE PATIENT. AFTER THE LEAD WAS REPLACED WITH A NEW LEAD, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCS LEAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 3877-45 V820540

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR