BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 2940569 · Received January 29, 2013

    Report

    Report Number
    1627487-2013-15107
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD- THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS- THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION- THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    DEVICE 4 OF 5. REFERENCE MFR REPORT NUMBERS: 1627487-2013-15104, 15105, 15106 AND 15108. THE PT HAD FOUR LEADS (THREE FROM THE SAME LOT AND ONE FROM A DIFFERENT LOT) AND TWO EXTENSIONS (FROM DIFFERENT LOTS) AS PART OF HER SCS SYSTEM. IT WAS REPORTED, THE PATIENT¿S SCS SYSTEM WAS EXPLANTED DUE TO INFECTION AT THE LEADS AND IPG POCKET SITE. NO ADD¿L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39566 DUAL EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL- NEUROMODULATION 3341 3729997

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention