BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION

    MDR report key: 10175333 · Received June 19, 2020

    Report

    Report Number
    1627487-2020-21957
    Event Type
    Injury
    Date Received
    June 19, 2020
    Date of Event
    June 5, 2020
    Report Date
    May 18, 2023
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION D4 - UNIQUE DEVICE IDENTIFIER (UDI #): THE UDI IS UNKNOWN BECAUSE THE LOT NUMBER WAS NOT PROVIDED. CORRECTION: SECTION G3 - THE PMA/510(K) # SHOULD HAVE BEEN P010032 INSTEAD OF BLANK. BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAD DISCOMFORT AT THE EXTENSION SITE DUE TO TWIDDLER'S SYNDROME. X-RAYS REVEALED EXTENSIVE LEAD COILING; HOWEVER DESPITE THE COILING, THE EXTENSION AND LEAD STAYED INTACT WITHOUT HARDWARE FAILURE. SURGICAL INTERVENTION TOOK PLACE WHERE THE EXTENSION WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640863 EXTENSION EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other