BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA PADDLE LEAD

    MDR report key: 2230420 · Received August 15, 2011

    Report

    Report Number
    1627487-2011-05030
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K090907
    Adverse Event
    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 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 RECEIVED HIS SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT EXPERIENCED SEVERE ABDOMINAL AND BACK PAIN IMMEDIATELY AFTER IMPLANT. HE SAID THAT IT FELT LIKE HE HAD A VERY BAD SUNBURN IN A 10" WIDE BELT AROUND HIS TORSO. THE PT ALSO SAID THAT THE NURSE IN THE RECOVERY ROOM TOLD HIM THAT HIS PAIN WAS DUE TO THE POSITION HE WAS IN DURING SURGERY, AND THAT THE PAIN WOULD GO AWAY SOON. AFTER 3 DAYS HE CONTACTED HIS DOCTOR. SINCE HIS DOCTOR WAS OUT OF TOWN HE WAS REFERRED TO SOMEONE ELSE. AFTER A CT SCAN THE PT WAS TOLD THAT THE PAIN WAS ATTRIBUTED TO THE LEAD'S POSITION AND POSSIBLY FLUID/FAT PRESSING AGAINST IT. HE WAS PRESCRIBED PAIN MEDICATION, AND WAS TOLD TO RETURN FOR FOLLOW-UP IN A WEEK. THE PAIN SLOWLY DIMINISHED OVER TIME, BUT HE STILL HAS PAIN AND CAN NOT COMFORTABLY WEAR CLOTHING OVER THE PAINFUL AREA. THE PT MET WITH TWO SJM REPRESENTATIVES FOR REPROGRAMMING. HE WAS GETTING STIMULATION IN HIS LEFT LEG AND TAILBONE, INSTEAD OF IN HIS RIGHT LEG AND RIGHT HIP. AN X-RAY WAS TAKEN, WHICH SHOWED THAT THE LEAD HAD MIGRATED 1 THORACIC SEGMENT, FROM T9 TO T10. MORE THAN 75% OF HIS POST-SURGICAL PAIN IS GONE. THE PT IS PLANNED FOR A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA PADDLE LEAD SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3371412

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788