BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 2980040 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-01335
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    March 1, 2013
    Report Date
    May 14, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    DEVICE 2 OF 3; REFERENCE MFR REPORT: 1627487-2013-1334, 1627487-2013-1336.

    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 3. REFERENCE MFR REPORT: 1627487-2013-1334, 1336. IT WAS REPORTED THE PATIENT IS EXPERIENCING A HEATING SENSATION AT HER IPG SITE WHILE CHARGING. SHE ALSO REPORTED SHE HAS HORNING AND STINGING AT LEAD SITE AND IPG SITES. A NEW LE CHARGER WAS SENT TO THE PATIENT AND REPROGRAMMING WAS DONE TO ADDRESS THE ISSUE. FOLLOW UP INFORMATION IDENTIFIED THE NEW CHARGER RESOLVED THE HEATING WHILE CHARGING ISSUE, BUT REPROGRAMMING DID NOT RESOLVE THE BURNING AND STINGING ISSUE. X-RAYS HAVE BEEN ORDERED AND THE PATIENT IS PENDING CONSULTATION WITH A SURGEON. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526097 EXCLAIM 8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3224 3335055

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention