BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT CABLE

    MDR report key: 2791423 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15554
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P820003/S70
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. THE CABLE INSULATION WAS INDENTED APPROXIMATELY ONE AND A HALF INCHES FROM THE PLUG. CONTINUITY TESTING WAS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITH THE CABLE, WHILE TESTING A LEAD DURING A CASE, PACING WAS UNABLE TO BE DONE AT 5 VOLTS. HOWEVER, WHEN THE PHYSICIAN OPTED TO GO DIRECTLY INTO THE NEW DEVICE, PACING WAS ABLE TO BE DONE AT 2.2 VOLTS. THE CABLE WAS RETURNED FOR ANALYSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTRUMENT CABLE DTB MEDTRONIC PUERTO RICO, INC. 5832

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Other 5068 IMPLANTABLE PACING LEAD| SESR01 IMPLANTABLE PULSE GENERATOR