BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2001145-MMJB STIM MODULE CABLE

    MDR report key: 562426 · Received May 12, 2004

    Report

    Report Number
    1222791-2004-00003
    Event Type
    Malfunction
    Date Received
    May 12, 2004
    Date of Event
    April 28, 2004
    Report Date
    April 29, 2004
    Manufacturer
    C.R. BARD, INC.
    Product Code
    DRQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO CO THAT THE "STIM 1 & 2 OUT" CONNECTOR PLUG ON THE CABLE WHICH IS ASSOCIATED WITH THE MULTI MODULE JUNCTION BOX, WAS INCORRECTLY PLUGGED INTO THE "TRIGGER IN" INPUT ON STAMP AMPLIFER. IT WAS ALSO REPORTED THAT WHEN A STIMULATOR SIGNAL WAS APPLIED TO THE CHANNEL 1 INPUT, THE SIGNAL WAS OBSERVED AT THE STIM 1 CHANNEL PACING SITE AND UNEXPECTEDLY AT THE STIM 2 CHANNEL PACING SITE. THE COMPLAINT IS UNDER INVESTIGATION AND THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2001145-MMJB STIM MODULE CABLE * DRQ C.R. BARD, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *