BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2102843 · Received April 12, 2011

    Report

    Report Number
    1627487-2011-00654
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 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 INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED AN SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THAT IMPEDANCE ISSUES WERE OBSERVED WITH THE LEAD DURING THE IMPLANT PROCEDURE. THE PHYSICIAN DISCONNECTED AND RECONNECTED THE LEAD FROM THE HEADER. HOWEVER, POST-OPERATIVE FOUR ELECTRODES MEASURED INVALID. EFFECTIVE STIMULATION COVERAGE WAS CAPTURED FOR THE PATIENT VIA PROGRAMMING. NO FURTHER ISSUES WERE REPORTED.

    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 3333115

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IMPLANT:| SCS ANCHOR: MODEL 1192| IMPLANT:| SCS ANCHOR: MODEL 1194| SCS IPG: MODEL 3788| IMPLANT: