BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4442974 · Received January 22, 2015

    Report

    Report Number
    3004209178-2015-01100
    Event Type
    Injury
    Date Received
    January 22, 2015
    Date of Event
    October 1, 2014
    Report Date
    December 30, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# V050963, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 3389S-40, LOT# V061015, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 64002, LOT# N312596, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE A FEW MONTHS PRIOR TO THIS REPORT. THE INS SITE WAS RED AND IRRITATED. THE INS AND EXTENSIONS WERE REMOVED AND THE LEADS WERE LEFT IMPLANTED. THE HEALTHCARE PROFESSIONAL (HCP) CUT THE EXTENSIONS DURING THE REMOVAL SO THEY WERE NOT ABLE TO SEE THE LEADS AT THAT TIME. THE INS AND EXTENSIONS WERE LATER REPLACED AND THE PATIENT WAS RECEIVING NORMAL THERAPEUTIC BENEFIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52547 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention