BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 3133297 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-08117
    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
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-08116. IT WAS REPORTED THE PATIENT HAD IPG (IMPLANTED PULSE GENERATOR) MIGRATION AND PAIN AT THE POCKET SITE; HENCE, THE IPG WAS EXPLANTED. IN ADDITION, THE PATIENT WAS RECEIVING ONLY 20% PAIN RELIEF ALTHOUGH THE PATIENT HAD PARASTHESIA IN THE CORRECT LOCATION. FOLLOW-UP INFORMATION SUGGESTED THE PATIENT DOES NOT HAVE ANY STIMULATION BECAUSE THE IPG WAS EXPLANTED AND THE LEAD WAS LEFT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223231 EXCLAIM 8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3224 2816054

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention