BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 2871461 · Received December 5, 2012

    Report

    Report Number
    1627487-2012-02752
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 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 RECEIVED TWO SURGICAL LEADS (FROM THE SAME LOT NUMBER) AS PART OF HIS SCS SYSTEM. IT WAS REPORTED MULTIPLE LEADS CONTACTS EXHIBITED INVALID IMPEDANCES AND THE PATIENT LOST STIMULATION. X-RAYS REVEALED LEAD FRACTURE. THE LEADS WERE EXPLANTED AND REPLACED AND STIMULATION WAS RESTORED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLAIM 8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3225 3584118

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL 1194 (2)| SCS IPG, MODEL 3788