BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7213155 · Received January 23, 2018

    Report

    Report Number
    3004209178-2018-01224
    Event Type
    Injury
    Date Received
    January 23, 2018
    Date of Event
    January 7, 2009
    Report Date
    February 15, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994761057
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387S-40, LOT# V183416, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V858673, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT'S IMPLANTED LEADS WERE NOT IN THE PROPER LOCATION FROM THE INITIAL IMPLANT. THE HCP WAS CONSIDERING ADDING STN LEADS, AS THE CURRENT ONES WERE IN THE VIM. THE HCP INDICATED THIS IS PARTIALLY WHAT LED THEM TO REMOVE THE SINGLE CHANNEL INSS AND REPLACE THEM WITH PRIMARY CHANNEL (PC) INSS. THEY TUNNELED A NEW PATH FOR ONE EXTENSION AND REPLACED EXTENSIONS CONNECTING THE EXISTING LEADS TO THE NEW PC INS. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP INDICATING THAT IT WAS MEDICAL JUDGEMENT THAT LED TO THE LEAD PLACEMENT IN THE VIM. THE PATIENT WAS RECEIVING ADEQUATE THERAPY BUT WAS CONSIDERING ADDING ANOTHER TWO LEADS IN THE FUTURE WITH A DIFFERENT TARGET LOCATION. THE PATIENT WAS CURRENTLY BEING CONTACTED BY THE CLINICIAN TO SCHEDULE A FOLLOW-UP VISIT TO TEST IMPEDANCES WHILE PALPATING VARIOUS AREAS TO SEE IF AN ELECTRICAL SHORT COULD BE CAPTURED. IT WAS NOTED THE LEFT SINGLE CHANNEL BATTERY WAS AT END OF SERVICE BEFORE EXPLANT, AND THE OTHER ONE WAS AT 2.8 V. BOTH INSS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55101 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602 00613994761057

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention