BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PISCES - QUAD

    MDR report key: 2971465 · Received February 19, 2007

    Report

    Report Number
    2649622-2007-03240
    Event Type
    Malfunction
    Date Received
    February 19, 2007
    Date of Event
    January 12, 2007
    Report Date
    February 6, 2007
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    GZB
    PMA / PMN Number
    K881491
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS RESULTS REVEALED MULTIPLE CONDUCTORS/WIRES WERE BROKEN.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR LEAD BREAKAGE. NO PT INJURY WAS REPORTED. THE PT RECOVERED WITHOUT SEQUELA. THE DEVICE WAS REPLACED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PISCES - QUAD GZB MDT PUERTO RICO OPERATIONS CO., VILLALBA 3487A V003531

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR IMPLANTABLE NEUROSTIMULATOR: MODEL 7427,| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, SERIAL# (B)(4)| SERIAL # (B)(4)