BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 3121950 · Received May 15, 2013

    Report

    Report Number
    1627487-2013-05688
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    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 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

    IT WAS REPORTED THE PT HAS BEEN EXPERIENCING SHOOTING PAIN IN HER UPPER AND LOWER EXTREMITIES WHEN STIMULATION IS ON. AN IMPEDANCE CHECK REVEALED HIGH IMPEDANCE ON SEVERAL CONTACTS. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. X-RAYS REVEALED NO ANOMALIES. AS A RESULT, THE PT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214508 EXCLAIM 8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3224 3639360

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention