BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD

    MDR report key: 3000503 · Received March 12, 2013

    Report

    Report Number
    3007566237-2013-00760
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    FINAL ANALYSIS OF THE LEAD REVEALED NO ANOMALY FOUND. FINAL ANALYSIS OF THE STYLET REVEALED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD TIP WAS OVERLY BENT FROM THE BOX AND WOULD NOT STEER APPROPRIATELY. IT WAS STATED THAT THE DEVICE WAS USED WITH IN THE PATIENT. HOWEVER, IT WAS ALSO STATED THAT THE DEVICE WAS REPLACED AND THE LEAD WAS RETURNED TO THE MANUFACTURER. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103232 LEAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 3778-60

    Patients

    Seq Age Sex Outcome Treatment
    1