BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD

    MDR report key: 3193385 · Received June 27, 2013

    Report

    Report Number
    2135394-2013-00009
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    August 1, 2013
    Manufacturer
    MEDTRONIC AFT
    Product Code
    LDF
    PMA / PMN Number
    K012452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, IT WAS NOTED THE TEMPORARY PACING LEAD WAS MODEL 6491. INITIALLY IT WAS REPORTED TO BE MODEL 6500F. THERE WAS A KNOT ON THE BROKEN LEAD 75MM DISTAL FROM THE ELECTRODE TIP. THE BROKEN CONDUCTOR WIRE EDGE HAD A CONICAL SHAPE, INDICATING A FRACTURE DUE TO WEAR ON THE CONDUCTOR WIRE. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE FRACTURE OBSERVED AT THE EDGE OF THE CONDUCTOR WIRE ON THE RETURNED PRODUCT IS MOST PROBABLY DUE TO FATIGUE, RELATED TO THE FLEXING OF THE CONDUCTOR WIRE, IN COMBINATION WITH EXTRA STRESS APPLIED ON THE LEAD AT THE ATTEMPTED EXPLANT. IT IS ALSO POSSIBLE THAT THE FRACTURE MAY BE DUE TO A TOO SHORT LENGTH OF CABLE LEFT IN THE CHEST CAVITY (75 MM). THE LENGTH OF TIME THIS WIRE WAS IMPLANTED WAS NOT REPORTED. OTHER POSSIBLE FACTORS FOR THE LEAD FRACTURE COULD BE, BUT ARE NOT LIMITED TO, THE POSITION OF THE ELECTRODE IN THE HEART TISSUE, PATIENT TISSUE CONDITION, THE IMPLANT TECHNIQUE, DISLODGEMENT, OR ANY OF THESE IN COMBINATION WITH EXTRA STRESS APPLIED ON THE LEAD. (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT HAS BEEN RETURNED AND CONTINUES TO UNDERGO ANALYSIS. (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 INDICATING THAT UPON REMOVAL OF THIS TEMPORARY PACING LEAD, IMPLANTED ONE WEEK, THE WIRE BROKE AND APART OF IT REMAINS IN THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292186 MEDTRONIC UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD ELECTRODE, PACEMAKER, TEMPORARY LDF MEDTRONIC AFT 6491 AAA053205F

    Patients

    Seq Age Sex Outcome Treatment
    1