BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM, 60 CM 16-ELECTRODE PADDLE LEAD

    MDR report key: 2133462 · Received June 15, 2011

    Report

    Report Number
    1627487-2011-03107
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    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 AND A PENTA SURGICAL LEAD ON (B)(6) 2011. PATIENT WAS IMPLANTED FOR LOW BACK AND BILATERAL LEGS BUT ONLY FELT STIMULATION IN ABDOMEN. THE PATIENT COULD BARELY FEEL STIMULATION IN HER BACK. THROUGH X-RAY, IT WAS CONFIRMED THE LEAD MIGRATED. THE DOCTOR REPOSITIONED THE LEAD. IMPEDANCE MEASUREMENT WAS LOW EXCEPT FOR 3 CONTACTS. DEVICE WAS NOT RETURNED FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 3MM, 60 CM 16-ELECTRODE PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3194888

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention SCS ANCHOR: MODEL 1194 (2)| IMPLANTED:| IMPLANTED:| SCS IPG: MODEL 3788