BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMINGTON

    MDR report key: 1561248 · Received December 11, 2009

    Report

    Report Number
    MW5013970
    Event Type
    Malfunction
    Date Received
    December 11, 2009
    Report Date
    December 11, 2009
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING A PACEMAKER GENERATOR CHANGE, WHO IS PACEMAKER DEPENDENT, HAD A TEMPORARY PACING CATHETER INSERTED FOR THE GENERATOR CHANGE TO SAFELY TAKE PLACE. AS A PRECAUTIONARY RULE, THE TEMPORARY PACING CATHETER WAS CONNECTED TO THE PSA CABLE AND THEN EXTERNAL PACING WAS BEGUN TO VERIFY INTEGRITY OF SYSTEM. NO PACING OCCURRED. THE CATHETER WAS CHANGED OUT AND RECONNECTED TO THE PSA CABLE. AGAIN, NO PACING OCCURRED. THE PSA CABLE WAS CHANGED AND PACING WAS POSSIBLE. THE PSA CABLE WAS DEFECTIVE. THIS IS A HUGE SAFETY RISK FOR PACEMAKER DEPENDENT PATIENTS. THE PSA CABLE MFR'S REFERENCE LOT # 090857 EXP DATE 03/2012. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: PACEMAKER DEPENDENT PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMINGTON PSA CABLE WITH ALLIGATOR CLIPS DSA REMINGTON MEDICAL, INC. S-101-97 090857

    Patients

    Seq Age Sex Outcome Treatment
    1