BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 7660021 · Received July 3, 2018

    Report

    Report Number
    3004209178-2018-14959
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    May 14, 2018
    Report Date
    October 25, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: (B)(4), UBD: 30-AUG-2021, UDI#: (B)(4); PRODUCT ID: 977A260, SERIAL/LOT #: (B)(4), UBD: 30-AUG-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 CONSUMER VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT COMPLAINED OF NOT GETTING RELIEF OF THE PAIN FROM STIMULATION. THE PATIENT STATED THAT THEY FEEL LIKE THEIR PAIN IS THE SAME AS BEFORE GETTING THE STIMULATION. THE PATIENT STATED THAT THEY HAVE BEEN HOLDING ONTO THE GROCERY CART WHEN AT THE STORE. THE PATIENT STATED THAT THEY HAD GREAT RELIEF UP UNTIL ABOUT 4-6 WEEKS AFTER IMPLANT AND SINCE HAS HAD A FEW REPROGRAMS BUT ISN'T GETTING THE SAME RELIEF. THE PATIENT WAS REPROGRAMMED ON "C" ON AN HD SETTING OVER 9/10 AT 90/1000. THE PATIENT WAS ALSO ADVISED TO NOT TURN STIMULATION OFF UNLESS DRIVING A VEHICLE. THE PATIENT HAD BEEN TURNING STIMULATION OFF WHEN DOING REHAB. THE PATIENT HAS A FOLLOW-UP ON (B)(6) TO SEE IF THE NEW PROGRAMMING WORKED AND WILL DISCUSS HOW TO PROCEED. THE IMPEDANCES WERE GREEN AND WITHIN NORMAL LIMITS. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. NO DEVICE ALLEGATIONS WERE MADE. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT HAD X-RAYS THAT SHOWED THE LEADS HAD MOVED SIGNIFICANTLY. THE HEALTHCARE PROVIDER WAS REFERRING THE PATIENT OUT FOR A LEAD REVISION. THE INDICATION FOR USE WAS SPINAL PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP WAS ABLE TO GET A HOLD OF THE PATIENT AND THE PATIENT STATED THEY NO LONGER USED THE STIMULATOR AND THAT THE DOCTOR THE PATIENT WAS REFERRED TO HAD SUGGESTED SURGERY INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502944 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention