BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 3890517 · Received June 4, 2014

    Report

    Report Number
    1627487-2014-23376
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    November 10, 2013
    Report Date
    May 12, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 DIAGNOSTIC TESTING REVEALED HIGH IMPEDANCE READINGS ON MULTIPLE LEAD CONTACTS. IT WAS ALSO REPORTED THE PT WAS UNABLE TO INCREASE STIMULATION AMPLITUDE. REPROGRAMMING WAS ABLE TO PROVIDE EFFECTIVE STIMULATION IN THE PT'S PAIN PATTERN AS WELL AS STIMULATION IN THE LEFT ARM (NEW PAIN); HOWEVER, STIMULATION COULD NOT BE OBTAINED IN HIS NECK (NEW PAIN). F/U INFO REVEALED THE PT UNDERWENT SURGICAL INVENTION WHERE THE PT'S LEAD WAS EXPLANTED AND REPLACED WITH A NEW ONE. THE PT REC'D EFFECTIVE STIMULATION IN THE DESIRED AREAS FOLLOWING THE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327724 EXCLAIM 8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3225 3608318

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other SCS IPG: MODEL 3788| IMPLANT DATE: