BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5158955 · Received October 19, 2015

    Report

    Report Number
    3004209178-2015-20882
    Event Type
    Injury
    Date Received
    October 19, 2015
    Report Date
    September 24, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    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# VA0Q174, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V101646, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT HE THOUGHT THE PATIENT HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) POCKET INFECTION, BUT WAS NOT POSITIVE. THE REP DID NOT KNOW WHEN THE INS AND EXTENSIONS WERE REMOVED. THE PATIENT WAS HAVING A NEW INS AND EXTENSIONS PLACED ON (B)(6) 2015. FOLLOW-UP RECEIVED FROM THE REP ON THE DAY OF REPLACEMENT REPORTED THAT THE PATIENT DID NOT PROCEED WITH THE STAGE TWO IMPLANT. THE LEADS WERE INFECTED AND WERE TO BE REMOVED INSTEAD. THE REP ASSUMED THE PATIENT WAS ON ANTIBIOTICS, BUT DID NOT KNOW FOR SURE. THE PATIENT'S INDICATIONS FOR USE WERE PARKINSON'S DUAL AND MOVEMENT DISORDERS. THE PATIENT OUTCOME WAS NOT REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690634 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention