BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 12294459 · Received August 9, 2021

    Report

    Report Number
    3004209178-2021-12092
    Event Type
    Injury
    Date Received
    August 9, 2021
    Date of Event
    July 15, 2021
    Report Date
    August 9, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977C265 ; SERIAL# (B)(4); IMPLANTED: (B)(6) 2021; EXPLANTED: (B)(6) 2021; PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977C265, SERIAL/LOT #: (B)(4) , UBD: 08-JUN-2025, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT THEY ARE WANTING TO DO STAT THORACIC MRI TO RULE OUT POTENTIAL EPIDURAL HEMATOMA. PT DEVELOPED PAIN ALL OVER AFTER HAVING SPINAL CORD STIMULATOR (SCS) SYSTEM IMPLANTED RECENTLY. CALLER HAS INFORMATION THAT PT GOT A NEW 97715 SCS SYSTEM PLACED. TECHNICAL SERVICE (TSS) REVIEWED PAST SCS SYSTEM THAT APPEARED INACTIVE. CALLER DOESN'T HAVE ANY FURTHER DETAILS BUT JUST KNOWS THAT PT HAD SCS SYSTEM IMPLANTED VERY RECENTLY, POSSIBLY TODAY. POST PADDLE IMPLANT (SAME DAY) PATIENT COMPLAINED OF SEVERE PAIN, NUMBNESS, AND WEAKNESS IN BLE. HCP DECIDED TO EMERGENTLY REMOVE SYSTEM FOLLOWING DAY. ISSUE IS NOT RESOLVED BECAUSE PATIENT CONTINUES TO HAVE PAIN, WEAKNESS, AND NUMBNESS. THE DAY AFTER PADDLE IMPLANT, HCP EMERGENTLY REMOVED SYSTEM. PER PHYSICIAN¿S PA, SOME STENOSIS AND A SMALL HEMATOMA WAS FOUND AROUND THE PADDLE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190381 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention