BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT CABLE

    MDR report key: 2812289 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03839
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 16, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P820003/S70
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; CABLE INSULATION IS FRACTURED AROUND WHOLE CABLE JUST ABOVE STRAIN RELIEF OF PLUG AND IS SHOWING THE TWO INTERIOR CABLES. STRAIN RELIEF IS PULLING AWAY FROM THE BLACK PART OF PLUG. ANALYSIS ALSO FOUND THE CABLE IS TWISTED THROUGHOUT LENGTH OF CABLE AND THE CABLE INSULATION IS FRACTURED APPROXIMATELY SIX INCHES FROM END OF PLUG. IT IS NOTED THE CABLE WAS BENT TO THE SIDE OF THE PLUG AND HAD ELECTRICAL TAPE HOLDING IT INTO PLACE WHEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLES OF THE EXTERNAL PULSE GENERATOR (EPG) WHICH HAVE BEEN IN USE ABOUT THREE MONTHS, OFTEN EXPERIENCE BROKEN CONNECTORS IN THE FIELD. GUIDANCE AND EXPLANATION WAS GIVEN TO AVOID SUCH SITUATIONS. DISPOSITION OF THE CABLES ARE UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE CABLES WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTRUMENT CABLE DTB MEDTRONIC, INC. 5433A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4) PATIENT CABLE