BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD LOW IMPEDANCE LEAD

    MDR report key: 1992001 · Received February 4, 2011

    Report

    Report Number
    6000153-2011-00879
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    MPROC, VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE LEAD AND STYLET WERE RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    DURING STIMULATION TESTING, THE PT WAS UNABLE TO FEEL STIMULATION WITH THE LEAD. THE LEAD WAS REPLACED. THERE WAS NO PT INJURY ASSOCIATED WITH THE EVENT. THE PT RECOVERED WITHOUT SEQUELA AFTER REMOVAL. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD LOW IMPEDANCE LEAD LGW MPROC, VILLALBA 3777 V558914004

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT# UNK| STIM ACCESSORY: MODEL STYLET/RESTORE| EXPLANTED:| IMPLANTED: