BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 10580032 · Received September 24, 2020

    Report

    Report Number
    2649622-2020-18363
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    September 21, 2020
    Report Date
    September 24, 2020
    Manufacturer
    MPRI
    Product Code
    MHY
    UDI-DI
    00643169752276
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT#: VA27NE2, IMPLANTED: (B)(6) 2020, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE RIGHT LEAD WAS MANGLED BUT IMPEDANCES WERE OKAY. THE LEFT LEAD LOOKED OKAY BUT HAD IMPEDANCES OVER 2000 OHMS. THE MANGLED LEAD WAS DISCOVERED DURING STAGE 2 OF THE IMPLANT PROCEDURE AND SAW IT WAS BETWEEN CONTACT 0 AND 1. THE EXTENSION WAS CONNECTED WITH NO ISSUES. THE PHYSICIAN NOTICED THE LEFT LEAD HAD SLIGHTLY OUT OF RANGE IMPEDANCES. RIGHT LEAD 3389S-40 MONOPOLAR: CASE & 11 1670 OHMS CASE & 10 1631 OHMS CASE & 9 1733 OHMS CASE & 8 1922 OHMS BIPOLAR: 11 & 8 3350 OHMS 11 & 9 3008 OHMS 11 & 10 2637 OHMS 10 & 8 3199 OHMS 10 & 9 2582 9 & 8 2801 OHMS LEFT: MONOPOLAR: CASE & 3 1928 OHMS CASE & 2 1685 OHMS CASE & 1 1744 OHMS CASE & 0 2056 OHMS (OUT OF NORMAL RANGE) BIPOLAR: 3 & 0 3803 OHMS 3 & 1 3405 OHMS 3 & 2 3118 OHMS 2 & 0 3431 OHMS 2 & 1 2911 OHMS 1 & 0 3321 OHMS THE EXTENSION WAS DISCONNECTED AND RECONNECTED FOR TROUBLESHOOTING. THE ISSUE DID NOT RESOLVE. CONTACT 0 WAS NOT GOING TO BE USED FOR PROGRAMMING. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043650 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MPRI 3389S-40 VA27NE2 00643169752276

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR