BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 7553481 · Received May 30, 2018

    Report

    Report Number
    3007566237-2018-01622
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    May 24, 2018
    Report Date
    July 24, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 10-OCT-2020, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE HCP OFFICE STATED THE IMPEDANCES REMAINED THE SAME, BUT THE PATIENT WAS GETTING VERY GOOD THERAPEUTIC BENEFIT FROM THE CONTACTS THAT WERE IN RANGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS). THE REP REPORTED THAT THERE WAS HIGH IMPEDANCE ON THE PATIENT'S RIGHT LEAD, FIRST DISCOVERED ON (B)(6) 2018. THE REP REPORTED THAT THE HEALTHCARE PROVIDER (HCP) HAD DIFFICULTY ACCESSING THE LEAD IN THE PATIENT'S SCALP AND HAD TO PULL ON THE END CAP. THE REP REPORTED THAT WHEN THEY DID SO, IT APPEARED THAT ONE OF THE ELECTRODES WAS DAMAGED WHICH CAUSED THE HIGH IMPEDANCE. THE REP REPORTED THE FOLLOWING IMPEDANCE RESULTS: C & 8: 22238 OHMS, C & 10: 15547 OHMS, C & 11: 30374 OHMS, 8 & 9: 21628 OHMS, 8 & 10: 35902 OHMS, 8 & 11: >40000 OHMS, 9 & 10: 14609 OHMS, 9 & 11: 29522 OHMS, 10 & 1: 16971 OHMS. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397566 EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR