BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PISCES - QUAD

    MDR report key: 858733 · Received May 31, 2007

    Report

    Report Number
    6000153-2007-01868
    Event Type
    Malfunction
    Date Received
    May 31, 2007
    Date of Event
    May 8, 2007
    Report Date
    May 8, 2007
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, VILLALBA
    Product Code
    GZB
    PMA / PMN Number
    K881491
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY DEVICE ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT; TWO LEADS WERE RETURNED FOR ANALYSIS: LOT NUMBERS V014073 OR V014317. A SUPPLEMENTAL MDR FOLLOW-UP REPORT WILL BE SENT TO FDA WHEN DEVICE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE HCP REPORTED, THE TEST LEAD WAS IMPLANTED AND THE SCS TRIAL WAS STARTED. DURING REMOVAL, THE LEAD COATING (INSULATION) WAS FRACTURED OR DAMAGED DURING EXPLANT AND THE PHYSICIAN TEMPORARILY STOPPED THE OPERATION. A SUBSEQUENT PROCEDURE LATER THE SAME DAY, USING FLUOROSCOPY SUCCESSFULLY REMOVED THE LEAD AND INSULATION MATERIAL; THE PT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PISCES - QUAD GZB MDT PUERTO RICO OPERATIONS CO, VILLALBA 3487A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention