BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2130673 · Received June 14, 2011

    Report

    Report Number
    1627487-2011-00811
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY; THEREFORE, THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE REPORTED EVENT. 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 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 # 1627487-2011-00810. THE PATIENT RECEIVED AN SCS SYSTEM INCLUDING AN IPG AND SURGICAL LEAD. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POCKET SITE. ORAL ANTIBIOTICS WERE PRESCRIBED AS TREATMENT, AND THE PATIENT IS RECOVERING. HIS SCS SYSTEM REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 3MM LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3315571

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention