BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44C

    MDR report key: 2780729 · Received October 5, 2012

    Report

    Report Number
    1627487-2012-06509
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: A MICROSCOPIC INSPECTION OF THE RETURNED LEAD CONFIRMED THERE WAS A KINK IN THE LEAD BODY WITH COMPLETE WIRE SEPARATION AT THE SITE OF THE KINK. THE KINK AND LEAD WIRE DAMAGE IS CONSISTENT WITH REPETITIVE STRESS TO THE LEAD WHILE IMPLANTED. THE DAMAGED LEAD WIRES RESULTED IN THE INVALID IMPEDANCES NOTED IN THE FIELD. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S LEAD WAS EXPLANTED AND REPLACED DUE TO INVALID IMPEDANCE. THE REPLACEMENT LEAD RESOLVED THE PT'S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44C SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3245 2838257

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention EXPLANT:| IMPLANT:| SCS IPG: MODEL 3608