BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 7703362 · Received July 19, 2018

    Report

    Report Number
    3004209178-2018-16188
    Event Type
    Injury
    Date Received
    July 19, 2018
    Date of Event
    July 12, 2018
    Report Date
    October 3, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3986A, LOT# N200155, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3986A, SERIAL/LOT #: UNKNOWN/N200155, (B)(6), (B)(4); PRODUCT ID: 3708360, SERIAL/LOT #: (B)(4), (B)(6), (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR COMPLEX REGIONAL PAIN SYNDROME TYPE I. THE PATIENT WAS HAVING THEIR IMPLANTABLE NEUROSTIMULATOR REPLACED DUE TO NORMAL BATTERY DEPLETION AND THE DEVICE REACHING THE ELECTIVE REPLACEMENT INDICATOR. PRIOR TO EXPLANT, AN IMPEDANCE TEST FOUND THAT ALL ELECTRODES WERE WITHIN NORMAL RANGE WITH ELECTRODE 0 BEING THE REFERENCE AND ELECTRODES 1, 2, AND 3 WERE BETWEEN 311 OHMS AND 334 OHMS. DURING THE PROCEDURE, 4 ELECTRODES WERE ¿OUT¿ DURING THE CONNECTIVITY CHECK. IT WAS REPORTED THAT CONTACTS 0 ¿ 3 SHOWED GREATER THAN 40,000 OHMS. IT WAS NOTED THAT THE INS WAS SWITCHED OUT. IT WAS NOTED THAT AFTER TRYING THE SECOND INS AND THE WIRELESS EXTERNAL NEUROSTIMULATOR (WENS), THE IMPEDANCES HAD COME BACK DOWN TO NORMAL ON SOME CONTACTS. AFTER TRYING THE SECOND IMPLANTABLE NEUROSTIMULATOR AND WIRELESS EXTERNAL NEUROSTIMULATOR, THE IMPEDANCES HAD COME DOWN ON SOME CONTACTS AND WERE 1025 OHMS. CONTACT 12 WAS 40,000 OHMS AND CONTACT 13 WAS 220 OHMS. THE INS WAS IMPLANTED WITH THE SECOND INS CONNECTED UP. THE CAUSE OF THE HIGH IMPEDANCES WAS UNKNOWN, AND THE HIGH IMPEDANCES HAD NOT RESOLVED AS OF (B)(6) 2018. A REVISION SURGERY FOR THE LEADS IS PLANNED, BUT NOT YET SCHEDULED. THERE ARE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED. REFER TO MANUFACTURER REPORT # 3004209178-2018-15858. REFER TO MANUFACTURER REPORT # 3004209178-2018-15858.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545317 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention