BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 7793084 · Received August 17, 2018

    Report

    Report Number
    3004209178-2018-18491
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Date of Event
    April 5, 2018
    Report Date
    August 28, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD; PRODUCT ID: 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. 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 PATIENT VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT PATIENT HAS NOT RECEIVED PAIN RELIEF SINCE HER SURGERY. SHE REPORTS SHE HAS EXPERIENCED A SIGNIFICANT FALL SINCE HER LAST X-RAYS HAVE BEEN TAKEN ONE MONTH AFTER SURGERY. WHICH WAS ALSO IT APPEARED THAT THE CONTACTS WITH POSSIBLE SHORTS MAY BE TOUCHING. IMPEDANCE TEST SHOWS 6, 7, 11, AND 12 HAVE POSSIBLE SHORTS DESPITE OHMS BEING BETWEEN 500 AND 800. MD ORDERED X-RAYS. WAITING FOR THE RESULTS. REP GAVE PATIENT A NEW PROGRAM WITH +- - ON 13, 14, AND 15. WITH 90/1000 AND ALSO SET UP BIPOLE AT THE TOP OF EACH LEAD FOR PROGRAMS B AND C FOR OTHER OPTIONS. THE ISSUE WAS NOT RESOLVED. HCP HAD NO FURTHER INFORMATION. PATIENT'S WEIGHT WAS ASKED BUT WILL NOT BE MADE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE FALL WAS NOT RELATED TO THE DEVICES/THERAPY. THE ROOT CAUSE OF THE SHORTS AND PATIENT NOT RECEIVING PAIN RELIEF WAS NOT DETERMINED. PATIENT WAS GOING TO HAVE X-RAYS TO SEE IF THE LEADS HAD MOVED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. THE PROVIDED INFORMATION WAS CONFIRMED WITH THE HCP. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633958 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR