BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2191542 · Received July 20, 2011

    Report

    Report Number
    1627487-2011-06007
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MED 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

    ON (B)(6) 2011, THE PT WAS IMPLANTED WITH A SURGICAL LEAD AS PART OF A STAGED TRIAL. IT WAS REPORTED THAT DURING THE TRIAL, SHE EXPERIENCED IMPEDANCE ISSUES FOR SEVERAL OF HER RIGHT SIDE LEAD CONTACTS AND AFTER THE PERMANENT IMPLANT, THE IMPEDANCE ISSUES WERE OBSERVED ON THE OPPOSITE SIDE. EFFORTS TO CAPTURE EFFECTIVE THERAPY COVERAGE FOLLOWING THE PERMANENT PROCEDURE HAVE YIELDED LIMITED SUCCESS. THE PT'S RIGHT SIDE COVERAGE IS REPORTEDLY ADEQUATE. A FULL DIAGNOSTIC TEST RECENTLY TAKEN REVEALED INVALID IMPEDANCE MEASUREMENTS FOR SEVERAL LEAD CONTACTS. A CONSULTATION WITH THE PHYSICIAN WILL BE SCHEDULED TO DISCUSS THE NEXT COURSE OF ACTION IN THIS MATTER.

    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 3228 3339641

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3788