BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 2831260 · Received November 6, 2012

    Report

    Report Number
    1627487-2012-11628
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    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

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT HAS TWO SCS SYSTEMS, AND RECEIVED TWO EXTENSIONS WITH THE SAME LOT NUMBER WITH HER CERVICAL SYSTEM. IT WAS REPORTED THE PATIENT HAD RECEIVED A SHOCK AND HAD FALLEN WHILE CHANGING A LIGHT BULB. THE PATIENT REPORTED SHE HAD DISCOMFORT NEAR HER RIGHT BREAST DUE TO THE EXTENSIONS. IT WAS REPORTED THERE WAS NO EROSION NOTED AT THE SITE. THE PATIENT MET WITH THE PHYSICIAN, HOWEVER, IT WAS REPORTED THE PHYSICIAN DID NOT PLAN TO UNDERTAKE INTERVENTION AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE EXTENSION SCS ENTENSIINO LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3290707

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 1192| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS LEAD: MODEL 3186