BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 9711055 · Received February 14, 2020

    Report

    Report Number
    1627487-2020-01594
    Event Type
    Injury
    Date Received
    February 14, 2020
    Date of Event
    September 12, 2019
    Report Date
    March 2, 2020
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05414734401913
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS ESTIMATED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-01592. IT WAS REPORTED THE PATIENT EXPERIENCED SHOCKING SENSATIONS AND INEFFECTIVE THERAPY (REFERENCE REG REPORT: 1627487-2019-09866). LATER, DIAGNOSTICS DISCOVERED THE LEAD WAS FRACTURED AND THE PATIENT'S IPG WAS INOPERABLE (REFERENCE REG REPORT: 1627487-2019-11068). AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPG AND LEAD WERE EXPLANTED AND REPLACED TO ADDRESS THE REPORTED ISSUES. EFFECTIVE THERAPY WAS ESTABLISHED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173392 PENTA 3MM LEAD, 60 CM SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 4387138 05414734401913

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SCS IPG