BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8217686 · Received January 4, 2019

    Report

    Report Number
    3004209178-2019-00214
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    December 31, 2018
    Report Date
    February 10, 2019
    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
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A275, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. PRODUCT ID: 977A275, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A275, SERIAL/LOT #: (B)(4), UBD: 29-DEC-2021, UDI#: (B)(4); PRODUCT ID: 977A275, SERIAL/LOT #: (B)(4), UBD: 29-DEC-2021, UDI#: (B)(4). 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) VIA A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. THE PATIENT REPORTED A SUDDEN LOSS OF THERAPY. THE REP MET WITH THE PATIENT AT THEIR HEALTHCARE PROFESSIONAL (HCP) OFFICE TO REVIEW THE RECENT X-RAY. THE REP NOTICED A SIGNIFICANT LEAD MIGRATION. LEAD 1 MIGRATED FROM THE MIDDLE OF T8 TO THE MIDDLE OF T7. LEAD 2 MIGRATED FROM THE TOP OF T7/T8 DISC SPACE TO THE MIDDLE OF T8. THE HCP CONFIRMED THE LEAD MIGRATION. THE REP EXPLAINED HOW A LEAD MIGRATION WOULD AFFECT THE HIGH DENSITY (HD) PROGRAMMING IN THE T9/T10 DISC SPACE AND HOW THAT WOULD CAUSE A SUDDEN LOSS. AN IMPEDANCE TEST RETURNED ALL ELECTRODES WITHIN NORMAL LIMITS. THE REP REPROGRAMMED BY MOVING THE (+/-) ARRAYS TO THE T9/T10 DISC SPACE AND INCREASED THE INTENSITY TO PERCEPTION. THE REP RE-EDUCATED THE PATIENT ON BENDING, LIFTING, AND TWISTING. THE PATIENT CONFIRMED HAVING NO TRAUMAS OR FALLS. HOWEVER, THE PATIENT OWNS 3 GREAT DANES THAT WEIGH MORE THAN THE PATIENT DOES. THE PATIENT EXPLAINED THAT THEIR CARE IS VERY PHYSICAL AND MAY HAVE CONTRIBUTED TO THE MIGRATING OF THE LEADS. THE REP INSTRUCTED THE PATIENT TO TEST THE CHANGES THAT WERE MADE AND TO FOLLOW UP NEXT WEEK. THE ISSUE WAS RESOLVED AND THE PATIENT WAS NOTED TO BE ALIVE WITH NO INJURY. NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) ON 2019-JAN-21. THE REP MET WITH THE PATIENT FOR A FOLLOW-UP VISIT REGARDING THEIR PREVIOUS REPROGRAMMING SESSION DUE TO LOSS OF THERAPY. THE PATIENT REPORTED GOOD OVERALL PAIN RELIEF SINCE LAST APPOINTMENT; HOWEVER THEY ARE EXPERIENCING SOME BREAKTHROUGH PAIN DURING PHYSICAL ACTIVITY. THE PATIENT RUNS HD T9/T10 DISC SPACE PROGRAMMING. DURING THEIR LAST REPROGRAMMING SESSION, THE REP ONLY PROGRAMMED THE ELECTRODES ON LEAD #1 THAT ALIGNS IN THE T9/T10 DISC SPACE. DURING TODAY¿S APPOINTMENT, THEY ALSO PROGRAMMED THE ELECTRODES ON LEAD #2 THAT ALIGN IN THE T9/T10 DISC SPACE. THEY ALSO ENCOURAGED THE PATIENT TO INCREASE INTENSITY 2 CLICKS BEFORE ANY PHYSICAL ACTIVITY. THEY ADVISED THE PATIENT TO FOLLOW-UP WITH THEM VIA A PHONE CALL IN ONE WEEK TO PROVIDE AN UPDATE REGARDING TODAY¿S PROGRAMMING CHANGES. NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10710 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR