BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3052270 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-02472
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 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

    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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-02473. THE PT HAS TWO SCS SYSTEM (CERVICAL AND THORACIC). IT WAS REPORTED THE PT WAS UNABLE TO COMMUNICATE WITH THE IPG ON HER LEFT SIDE AND AN X-RAY VERIFIED THE IPG HAD FLIPPED. F/U IDENTIFIED THE PT HAD FLIPPED HER IPG BACK OVER AND IT WAS FUNCTIONING PROPERLY. ADD'L F/U INDICATED THE PT WANTS BOTH OF HER SYSTEMS REMOVED. IT WAS REPORTED THE PT HAD FLIPPED THE IPG SEVERAL TIMES AND TOLD THE PHYSICIAN SHE WANTED IT OUT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. AS THE AFFECTED IPG IS CURRENTLY UNK, BOTH OF THE PT'S IPGS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139545 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 2839810

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Required Intervention SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: