BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 60-CM SCS PADDLE LEAD

    MDR report key: 2212559 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-04022
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 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

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. THE LEAD WAS RETURNED WITH THE STIMULATION END CUT OFF AND MISSING. NO FUNCTIONAL TESTING COULD BE PERFORMED. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AND 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 HIS SCS SYSTEM, INCLUDING A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THE PATIENT WAS FEELING PAINFUL STIMULATION IN HIS LEFT ARM. THE REPORTED PAIN PATTERN WAS BILATERAL ARM AND LEFT SHOULDER. THE LEAD WAS EXPLANTED ON (B)(6) 2011. IT WAS REPORTED THE PATIENT MAY 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 SCS PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3224 2798859

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SCS LEAD: MODEL 3268| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS LEAD ANCHOR: MODEL 1194 (2)