BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 3133436 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-06318
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    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 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-06317, IT WAS REPORTED DURING THE IPG REPLACEMENT PROCEDURE, REPORTED IN MEDWATCH 1627487-2013-03528, THE LEADS WERE TESTED PRE-OPERATIVE AND IT WAS FOUND THE LEADS HAD INVALID CONTACTS. THE PHYSICIAN REPLACED THE LEADS WITH NEW ONES. THE PT IS NOW RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223556 EXCLAIM 8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3225 3170806

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1194(X2)| SCS IPG: MODEL 3788