BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL 4 60-CM LENGTH EXTENSION

    MDR report key: 2153345 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-03202
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    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: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULT: INSPECTION OF THE EXTENSIONS REVEALED EXTENSION "A" WAS KINKED WITH BROKEN WIRES APPROXIMATELY 21 CM FROM THE CONNECTOR BLOCK END. THE TERMINAL ENDS WERE CUT FROM BOTH EXTENSIONS CONSISTENT WITH EXPLANT DAMAGE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION 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

    DEVICE 6 OF 6. REFERENCE MFR REPORT 1627487-2011-03154, REFERENCE MFR REPORT 1627487-2011-03198, REFERENCE MFR REPORT 1627487-2011-03199, REFERENCE MFR REPORT 1627487-2011-03200, REFERENCE MFR REPORT 1627487-2011-03201.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL 4 60-CM LENGTH EXTENSION EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3346 3213748

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention