BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 60-CM LENGTH PADDLE LEAD

    MDR report key: 2230845 · Received August 23, 2011

    Report

    Report Number
    1627487-2011-04055
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    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

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT. HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR FUNCTIONALITY. THE DEVICE WAS, THEREFORE, APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 3 OF 5. REFERENCE: 1627487-2011-04053; 1627487-2011-04054; 1627487-2011-04056; 1627487-2011-04080. ON (B)(6) 2011, THE PT BEGAN A TRIAL IMPLANT WHICH INCLUDED 3 SURGICAL LEADS (2 FROM THE SAME LOT), TWO SURGICAL EXTENSIONS, AND AN ANCHOR. ON (B)(6) 2011, AN IPG WAS SCHEDULED TO BE IMPLANTED. THE PHYSICIAN NOTICED POSSIBLE SIGNS OF INFECTION. DERMATITIS WAS FOUND AT THE EXIT SITE OF THE EXTENSION. THE PHYSICIAN REMOVED THE EXTENSIONS AND IMPLANTED NEW EXTENSIONS. THE PHYSICIAN LEFT THE LEADS IMPLANTED, AND DID NOT IMPLANT THE IPG AT THIS TIME. THE OLD EXTENSIONS WERE DISCARDED. FOLLOW UP REVEALED THE PHYSICIAN PROVIDED PRE-OPERATION ANTIBIOTIC, AND SUSPECTED THE PT HAD NOT FOLLOWED ANTIBIOTIC PROTOCOL OR PROPER HYGIENE. IT WAS REPORTED THE PT IS TO BE REIMPLANTED AT A LATER DATE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLAIM 60-CM LENGTH PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3224 3293009

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention