BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2010849 · Received March 3, 2011

    Report

    Report Number
    1627487-2011-00283
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    AFTER A SUCCESSFUL TRIAL PROCEDURE, THE PT WAS IMPLANTED WITH A SURGICAL LEAD ON (B)(6) 2010 FOR LOW BACK PAIN. IT WAS REPORTED THAT SHE HAS BEEN RECEIVING STIMULATION IN HER RIBS AND ABDOMEN SINCE IMPLANT. EFFORTS TO RESOLVE THIS MATTER VIA REPROGRAMMING HAVE BEEN UNSUCCESSFUL. IT IS SUSPECTED THAT THE PT¿S STIMULATION ISSUE IS A RESULT OF THE PLACEMENT OF THE SURGICAL LEAD. A CONSULTATION WITH THE PT¿S PAIN PHYSICIAN HAS BEEN SCHEDULED AND A DECISION WILL BE MADE REGARDING SURGICAL INTERVENTION. 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 3199504

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention