BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD 387460 OCTAD LZ TST STM CMP 60CM

    MDR report key: 3253033 · Received July 29, 2013

    Report

    Report Number
    6000153-2013-00145
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 5, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE STYLET FOUND NO SIGNIFICANT ANOMALY, THE STYLET WIRE WAS BENT WHICH CAUSED THE LEAD BODY TO LOOK WAVY. IT WAS NOTED WHEN THE STYLET WAS WITHDRAWN, THE LEAD BODY WAS STRAIGHT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN BEGAN TO USE A LEAD BUT THE LEAD APPEARED A ¿BIT WAVY¿ AND THE PHYSICIAN REQUESTED A NEW ONE. IT WAS NOTED THAT THE LEAD WAS NOT CONNECTED TO AN EXTERNAL NEUROSTIMULATOR (ENS) OR AN IMPLANTABLE NEUROSTIMULATOR (INS) SO THERE WAS NO INDICATION THAT THE LEAD WAS CAPABLE OR INCAPABLE OF DELIVERING STIMULATION. ADDITIONAL INFORMATION RECEIVED THAT THE LEAD WAS NOT PLACED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CURVES ON THE LEAD WERE FOUND UPON REMOVAL FROM PACKAGING AND REMOVAL OF STYLET. THE PHYSICIAN WAS CONCERNED WITH DRIVING THE LEADS. REQUESTED ANALYSIS OF "DEFECTIVE OR HEAT IMPACTED." IT WAS NOTED THERE WAS NO PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352329 LEAD 387460 OCTAD LZ TST STM CMP 60CM STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW NEURO - VILLALBA 387460 VA064XG

    Patients

    Seq Age Sex Outcome Treatment
    1