BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA SURGICAL LEAD

    MDR report key: 2003937 · Received February 24, 2011

    Report

    Report Number
    1627487-2011-01169
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORDS FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY. THE PRODUCT WAS REWORKED AND RELEASED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. 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 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

    THE PT REC'D AN SCS SYSTEM, INCLUDING AN IPG AND PADDLE LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT FELT THE PADDLE LEAD WAS UNCOMFORTABLE AND THE STIMULATION WAS INEFFECTIVE. THE PHYSICIAN EXPLANTED THE PT'S SYSTEM ON (B)(6) 2011. THE EXPLANTED LEAD WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FURTHER ISSUES HAVE BEEN REPORTED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL- NEUROMODULATION DIVISION 3228 2867514

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention