BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 4241400 · Received November 10, 2014

    Report

    Report Number
    2025587-2014-00870
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    September 24, 2014
    Report Date
    January 16, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LDF
    PMA / PMN Number
    K012460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. THE MONOFILAMENT AND THE CONNECTOR PINS WERE VERIFIED TO MEET THE DESIGN SPECIFICATIONS. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT, AND NO SIMILAR COMPLAINTS WERE FOUND FOR THIS LOT. THE RETURNED PRODUCT DID NOT IDENTIFY A ROOT CAUSE FOR THE SEPARATION OF THE MYOCARDIAL NEEDLE FROM THE WIRE. THIS TYPE OF FRACTURE IS INHERENT TO THE HANDLING OF THE PRODUCT. BEFORE STERILE PACKAGING, BOTH THE CURVED AND THORACIC NEEDLES ARE INSERTED INTO A SILICONE TUBING; IT IS VERY UNLIKELY, GIVEN THE MANUFACTURING HANDLING, AND AMOUNT OF INSPECTION APPLIED TO THE PRODUCT, THAT THE MONOFILAMENT HAD BEEN DELIVERED DAMAGED IN THE STERILE PACKAGE.

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. (B)(4)

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE PREPARATION OF THIS TEMPORARY PACING WIRE, THE PERFUSIONIST NOTICED THE MYOCARDIAL NEEDLE HAD SEPARATED FROM THE WIRE. THE DEVICE WAS REPLACED TO COMPLETE THE OPERATION. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722634 MEDTRONIC ELECTRODE, PACEMAKER, TEMPORARY LDF MEDTRONIC HEART VALVES DIVISION 6495J AAE042203

    Patients

    Seq Age Sex Outcome Treatment
    1