BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 8645680 · Received May 28, 2019

    Report

    Report Number
    3004209178-2019-10324
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    August 9, 2018
    Report Date
    May 28, 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
    MN, 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. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: (B)(4), UBD: 21-JUN-2022, UDI#: (B)(4); PRODUCT ID: 977A260, SERIAL/LOT #: (B)(4), UBD: 07-MAY-2022, UDI#: (B)(4). 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¿S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. THE REP REPORTED THAT THE PATIENT WAS HAVING A LEAD REVISION DUE TO POOR PLACEMENT OF THE LEAD SINCE IMPLANT. THE REP REPORTED THAT THE PATIENT WAS GETTING RIB STIMULATION. THE REP REPORTED THAT THEY MET WITH THE PATIENT A COUPLE OF TIMES TO REPROGRAM TO RESOLVE THE ISSUE AND HE NOTED THAT THE TIMES HE DID MEET AND REPROGRAM SEEMED TO HAVE RESOLVED THE ISSUE FOR A TIME AND ¿A WEEK INTO IT¿ THE STIMULATION LOCATION REVERTED BACK. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON 2019-05-06. THE REP REPORTED THAT THE CAUSE OF THE POOR LEAD PLACEMENT AND RIB STIMULATION WAS THAT THE LEADS MOVED MORE MIDLINE AND LOWER IN THE EPIDURAL SPACE. THE REP REPORTED THAT THE LEAD REVISION RESOLVED THE POOR LEAD PLACEMENT AND RIB STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON 2019-05-21. THE REP NOTED THAT HE MEANT THAT THEY MOVED THE LEAD MORE MIDLINE DURING THE REVISION NOT THAT IT HAD ACTUALLY MIGRATED. THE REP REPORTED THAT THE LEAD WASN'T DIFFICULT TO PLACE. THEY TRIED TO REPLACE THE TRIAL LEAD PLACEMENT AND ON X-RAY IT LOOKED FINE. THE REP NOTED THAT THE DOCTOR DIDN'T TEST INTRA-OPERATIVELY, SO THEY DIDN'T KNOW ABOUT THE PLACEMENT AND THEY TRIED WORKING WITH WHAT WAS THERE. THE REP REPORTED THAT EACH ONE OF THE TEAM MEMBERS HAD REPROGRAMMED THE PATIENT AND IT WAS NOTICED EARLY ON THAT THE LEAD WASN'T IN A GOOD SPOT BECAUSE WITHIN A FEW DAYS OF REPROGRAMMING IT WOULD MOVE AGAIN. THE REP REPORTED THAT PART OF THE ISSUE WAS THAT WITHIN A MONTH OF IMPLANT THE PATIENT WAS LIFTING HEAVY EQUIPMENT IN THE GARAGE AND THE REP THOUGHT THAT THIS/THE PATIENT CAUSED THE LEADS TO MOVE SLIGHTLY. THE REP REPORTED THAT HE BECAME AWARE OF THE REVISION A COUPLE OF DAYS BEFORE SURGERY. THE REVISION OCCURRED ON (B)(6) 2019. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439052 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention