BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 1990712 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-00154
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE PT WAS IMPLANTED WITH A SURGICAL LEAD ON (B)(6) 2010 FOR LOW BACK AND HIP PAIN. IT WAS REPORTED THAT THE PT'S STIMULATION COVERAGE WAS INADEQUATE. X-RAYS WERE TAKEN; HOWEVER, NO VISIBLE ANOMALIES WERE CONFIRMED. IN AN EFFORT TO RESOLVE THIS MATTER, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO REPOSITION THE PT'S LEAD. FOLLOW-UP ON THE PT FOUND THAT HE IS NOW RECEIVING EFFECTIVE STIMULATION FOLLOWING THE REVISION PROCEDURE. NO PRODUCT WAS EXPLANTED, AND NONE WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    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 DIVISION 3228 3175686

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention