BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORION RC SCS IPG

    MDR report key: 18803294 · Received February 28, 2024

    Report

    Report Number
    1627487-2024-07246
    Event Type
    Injury
    Date Received
    February 28, 2024
    Date of Event
    January 18, 2024
    Report Date
    February 28, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067040763
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT IS ESTIMATED. A PATIENT HAD A CHARGER COMMUNICATION ISSUE WAS REPORTED TO ABBOTT. THE REP MET WITH THE PATIENT AND WAS ABLE TO GET THE IPG TO CHARGE BY HOLDING THE CHARGING AT AN ANGLE. AFTER MULTIPLE ATTEMPTS OF CHARGING WITHOUT SUCCESS, THE PATIENT MADE AN APPOINTMENT FOR A POCKET REVISION CONSULT. FLUOROSCOPY IMAGING SHOWED THEIR IPG HAD ROTATED SO THE FLAT PART OF THE IPG WAS FACING UP AND DOWN. AS A RESULT, THE PATIENT HAD A POCKET REVISION WHERE THE IPG AND POCKET WERE REPOSITIONED, AND CHARGING WAS SUCCESSFUL. THERAPY WAS RESTORED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT'S IPG WAS UNABLE TO COMMUNICATE WITH CHARGER. MULTIPLE ATTEMPTS AT TROUBLESHOOTING WERE ATTEMPTED TO NO AVAIL INCLUDING ADJUSTING THE DISTANCE BETWEEN THE CHARGING PADDLE AND THE IPG AS WELL AS REPOSITIONING THE CHARGING PADDLE. DURING TROUBLESHOOTING IT WAS NOTED THAT THE IPG WAS ABLE COMMUNICATE WITH TWO DIFFERENT CLINICIAN PROGRAMMERS (CPS) WITH NO ISSUES AND THE CHARGER ITSELF WAS WORKING FINE. X-RAYS WERE TAKEN USING FLUOROSCOPY AND SHOWED THE IPG HAD ROTATED SO THE FLAT PART OF THE IPG WAS FACING UP AND DOWN. NO ACCIDENTS, FALLS, TRAUMA, OR WEIGHT FLUCTUATIONS WERE REPORTED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE IPG AND THE IPG POCKET WERE REPOSITIONED. EFFECTIVE THERAPY WAS RESTORED AND IPG WAS SUCCESSFULLY RECHARGED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896703 ORION RC SCS IPG SCS IPG LGW ABBOTT MEDICAL 32400 10077965 05415067040763

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS PERCUTANEOUS LEAD (2)