BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 3110699 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-04576
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    January 30, 2013
    Report Date
    April 19, 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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-04577. IT WAS REPORTED THE PATIENT WAS UNABLE TO INCREASE THE AMPLITUDE OF THE STIMULATION DUE TO AUTO REDUCTION. THE PATIENT WAS UNABLE TO RECEIVE ANY STIMULATION. FOLLOW UP IDENTIFIED THE PHYSICIAN OPTED TO REPLACE BOTH LEADS WITH TWO NEW LEADS (OF THE SAME MODEL). IT WAS REPORTED THE PATIENT RECEIVED EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205880 EXCLAIM 8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3225 3441186

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS ANCHOR: MODEL 1194(2)| IMPLANT:| SCS IPG: MODEL 3788| IMPLANT: