BEUDAMED
    FDA Adverse Event Other Summary report: N

    FL-601-97

    MDR report key: 2015765 · Received March 8, 2011

    Report

    Report Number
    1056553-2011-00001
    Event Type
    Other
    Date Received
    March 8, 2011
    Date of Event
    December 24, 2010
    Report Date
    March 8, 2011
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    DSA
    PMA / PMN Number
    K971968
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE SUSPECT CABLE FROM THE REPORTED EVENT HAS NOT BEEN RETURNED FROM THE CUSTOMER. SAMPLES OF THE (B)(4) CABLE IN REMINGTON MEDICAL'S FINISHED GOODS INVENTORY FROM THE SAME LOT AS THE SUSPECT PRODUCT WERE PULLED (1 BOX OF 5 CABLES) FOR TEST EVAL. ALL FIVE CABLE SAMPLES WERE HIPOT (HIGH POTENTIAL, OR HIGH VOLTAGE) TESTED AND TESTED FOR FIT WITH THE 5388 MEDTRONIC EPG, ACCORDING TO REMINGTON MEDICAL'S WORK INSTRUCTION FOR CABLE HIPOT TESTING AND INSPECTION; ALL CABLES PASSED TESTING (NOTE THAT EACH CABLE MUST PASS THIS TESTING PRIOR TO BEING PLACED INTO FINISHED GOODS INVENTORY). ADDITIONALLY, BECAUSE THE COMPONENT OF THE CABLE (THE CONNECTOR) THAT ATTACHES TO THE EPG IS MOLDED IN ONE OF FOUR MOLD CAVITIES AT REMINGTON MEDICAL, IT WAS CONFIRMED THAT THE SAMPLES TESTED INCLUDED CONNECTOR COMPONENTS FROM EACH OF THE FOUR MOLD CAVITIES. THE DEVICE HISTORY RECORD FOR THE AFFECTED LOT OF CABLES WAS REVIEWED, AND NO MFG-RELATED NON-CONFORMANCES WERE ASSOCIATED WITH THE LOT. ONE LOT OF CONNECTOR COMPONENTS WAS USED IN THE AFFECTED LOT OF CABLES, AND THE DEVICE HISTORY RECORD FOR THE LOT OF THESE CONNECTORS WAS REVIEWED AS WELL; NO MFG-RELATED NON-CONFORMANCES WERE FOUND FOR THIS COMPONENT.

    Description of Event or Problem · 1

    A REP FROM THE CUSTOMER'S RISK MANAGEMENT DEPARTMENT CONTACTED REMINGTON MEDICAL ON (B)(6) 2011 AND REPORTED THAT WHILE A PT WAS UNDERGOING TEMPORARY PACING DURING A PROCEDURE ON (B)(6) 2010, TO IMPLANT A PERMANENT PACEMAKER, PACING STOPPED DURING THE PROCEDURE AND THE PT FLAT-LINED. THE TEMPORARY PACING SYSTEM IN USE DURING THE EVENT INCLUDED REMINGTON MEDICAL'S (B)(4) CABLE, A 5388 MEDICAL EPG, AND A TEMPORARY PACING CATHETER. THE PT RECOVERED FOLLOWING 30 SECONDS OF CHEST COMPRESSION AND PACING WAS RESUMED USING THE SAME TEMPORARY PACING CATHETER AND 5388 MEDTRONIC EPG AND A NEW FL-(B)(4) CABLE; THE PERMANENT PACEMAKER WAS THEN IMPLANTED. A TECHNICIAN INVOLVED WITH THE PROCEDURE STATED THAT THE (B)(4) CABLE'S CONNECTION TO THE 5388 MEDTRONIC EPG SEEMED TO BE LOOSE PRIOR TO THE CESSATION OF PACING. THE PT WAS IN STABLE CONDITION AFTER THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FL-601-97 DISPOSABLE SURGICAL CABLE DSA REMINGTON MEDICAL, INC. FL-601-97 102717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening