BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 60-CM LENGTH SCS PADDLE LEAD

    MDR report key: 2230819 · Received August 23, 2011

    Report

    Report Number
    1627487-2011-04048
    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: A REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT; HOWEVER THE IDENTIFIED NONCONFORMANCE DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY. THE DEVICE WAS, THEREFORE, APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED 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 1 OF 2. REFERENCE: 1627487-2011-04049. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THE PT CONTACTED THE PHYSICIAN REGARDING SORENESS AT THE LEAD INCISION SITE. TESTING REVEALED THAT HER SEDIMENTATION RATE (SED RATE) WAS HIGH; NO CULTURE WAS TAKEN. THE PHYSICIAN PLACED THE PT ON AN ORAL ANTIBIOTIC. IT WAS REPORTED THE SCS SYSTEM IS FUNCTIONING AS IT SHOULD. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 60-CM LENGTH SCS PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3334170

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788