BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA SURGICAL LEAD

    MDR report key: 2092704 · Received May 10, 2011

    Report

    Report Number
    1627487-2011-02578
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 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 REC'D HER SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2011. IT WAS REPORTED THE PT FELT AN EXTREME RADIATING BAND OF ABDOMINAL AND RIB PAIN IMMEDIATELY FOLLOWING THE IMPLANT PROCEDURE. ACCORDING TO THE PHYSICIAN, THE PAIN THE PT WAS FEELING WAS DUE TO THE USE OF THE DURAL SEPARATOR CAUSING DOWNWARD FORCE ON SPINAL CORD. IT IS UNK IF THE EPIDURAL SPACE WAS ASSESSED PRIOR TO IMPLANT. DURING THE IMPLANT, THE PHYSICIAN MADE THREE ATTEMPTS TO PLACE THE LEAD BEFORE HE WAS SUCCESSFUL AS THE PT HAD A SMALL EPIDURAL SPACE. THE PT WAS PROVIDED WITH AN EXTERNAL PAIN PUMP POSTOPERATIVE; HOWEVER HER PAIN WAS NOT WELL MANAGED VIA THE PUMP. NINE DAYS LATER THE LEAD WAS SURGICALLY REPOSITIONED. NO FURTHER PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 3194888

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS IPG: MODEL 3788| IMPLANT: