BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2010833 · Received March 3, 2011

    Report

    Report Number
    1627487-2011-00289
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS ONE THAT DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND THE DEVICE WAS APPROVED FOR USE. 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 2 OF 3. REF MFR REPORT #S 1627487-2011-00288 AND 1627487-2011-00290. THE PT RECEIVED AN SCS SYSTEM ON (B)(6) 2011 AS PART OF A PAIN REGISTRY STUDY. THE SYSTEM INCLUDED AN IPG, SURGICAL LEAD AND TWO LEAD ANCHORS. IT WAS REPORTED THAT THE DEVICES WERE EXPLANTED ON (B)(6) 2011 DUE TO AN INFECTION SHE ACQUIRED FROM A RECENT ORAL SURGERY. NO FURTHER INFO 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 DIV 3228 3259587

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention