BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA SURGICAL LEAD

    MDR report key: 1993829 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-02038
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    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

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE THE LEAD MULTIPLE TIMES. ONCE THE LEAD WAS IN THE DESIRED POSITION, AN IMPEDANCE CHECK OF THE LEAD FOUND THAT ONE OF THE LEAD CONTACTS WAS INVALID. THE LEAD WAS EXPLANTED AND REPLACED. THE EXPLANTED LEAD WAS RETURNED TO THE MFR FOR ANALYSIS. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL -NEUROMODULATION 3228 3252464

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention