BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PISCES-QUAD

    MDR report key: 3240719 · Received July 22, 2013

    Report

    Report Number
    6000153-2013-00139
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE STYLET WAS REMOVED, THE LEAD SEPARATED FROM THE PROTECTIVE COVERING. THE LEAD WAS NOT USED, AS THIS OCCURRED PRIOR TO PLACEMENT. THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341921 PISCES-QUAD STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB NEURO - VILLALBA 3888-56 VA08QWY

    Patients

    Seq Age Sex Outcome Treatment
    1