BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTAD COMPACT LEAD

    MDR report key: 2053495 · Received March 1, 2011

    Report

    Report Number
    6000153-2011-01507
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 11, 2011
    Manufacturer
    MPROC, VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    RECEIVED INFO THAT BEGINNING IN (B)(6) 2010, THE PT EXPERIENCED CHANGING STIMULATION PATTERNS. THE DEVICE WAS INTERROGATED AND IMPEDANCES WERE FOUND TO BE >10,000 OHMS. A REVISION WAS SCHEDULED. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTAD COMPACT LEAD LGW MPROC, VILLALBA 3878 V6321441

    Patients

    Seq Age Sex Outcome Treatment
    1