BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 7732850 · Received July 30, 2018

    Report

    Report Number
    3004209178-2018-16973
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    July 17, 2018
    Report Date
    October 1, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, (B)(4). PERTAIN TO PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 977A260 (B)(4) IMPLANTED: (B)(6)2018. PRODUCT TYPE LEAD PRODUCT ID 977A260 (B)(4) IMPLANTED: (B)(6)2018 PRODUCT TYPE LEAD MEDTRONIC, INC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) OF A CLINICAL STUDY REGARDING A PATIENT. IT WAS REPORTED THAT THERE WAS SLIGHT LEAD MIGRATION IN BOTH LEADS. THE LEFT LEAD MIGRATED FROM THE TOP OF T8 TO THE BOTTOM OF T7 AND THE RIGHT LEAD MIGRATED FROM THE MIDDLE OF T8 TO THE TOP OF T8. THE OUTCOME WAS NOTED AS RECOVERED/RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT IN A CLINICAL STUDY WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT¿S LOW BACK PAIN HAD WORSENED/INCREASED FROM BASELINE ON VAS 61/100 FROM 55/100. IT WAS NOTED THAT THE EVENT WAS NOT RELATED TO THE STUDY PROCEDURE, NOT RELATED TO THE NEUROSTIMULATOR, NOT RELATED TO THE LEADS, NOT RELATED TO THE EXTERNAL STUDY DEVICE, AND NOT RELATED TO THE SPINAL CORD STIMULATION THERAPY; HOWEVER, IT WAS NOTED THAT INTERVENTIONS INCLUDED INTERROGATING THE DEVICE, REPROGRAMMING, AND X-RAY DIAGNOSTIC TESTING, WHICH SHOWED THERE WAS A SLIGHT LEAD MIGRATION. REPROGRAMMING WAS CONDUCTED AND THE OUTCOME OF THE EVENT WAS NOTED TO BE RECOVERING/RESOLVING. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) OF A CLINICAL STUDY REGARDING A PATIENT. IT WAS REPORTED THAT BOTH OF THE LEADS MIGRATED SLIGHTLY. THE HCP STATED THAT THE DEVICE WAS REPROGRAMMED, AND THERAPY WAS OPTIMIZED. IT WAS NOTED THAT SINCE THERE WAS ONLY A SLIGHT MIGRATION, NO INTERVENTION WAS NECESSARY. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575594 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR