BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 7290375 · Received February 22, 2018

    Report

    Report Number
    1627487-2018-01728
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    February 5, 2018
    Report Date
    December 9, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. THE MANUFACTURER HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE DEVICE PRODUCT CODE SHOULD HAVE BEEN LGW RATHER THAN GZB. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT ACCESSIBLE FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAS LOST EFFECTIVE STIMULATION DUE TO LEAD MIGRATION. AN X-RAY WAS TAKEN TO CONFIRM MIGRATION. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133501 PENTA 3MM LEAD, 60 CM SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 5197080

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other MODEL 3789, SCS IPG