BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8704310 · Received June 17, 2019

    Report

    Report Number
    3004209178-2019-11714
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Report Date
    July 1, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V712879, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V712879, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 28-FEB-2014, UDI#: (B)(4); PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 28-FEB-2014, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40, LOT# V712879, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID: 3387S-40, LOT# V712879, IMPLANTED: (B)(6) 2011, 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 PROVIDER (HCP) REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF MOVEMENT DISORDERS. IT WAS REPORTED THE PATIENT WAS HAVING AN MRI TO CHECK THE LEAD PLACEMENT. NO ADDITIONAL INFORMATION WAS AVAILABLE. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP STATING THE REASON FOR CHECKING THE LEAD PLACEMENT WAS THE PATIENT HAD REASONABLY GOOD VIM - DBS BENEFIT FOR HER ESSENTIAL TREMOR WHICH GRADUALLY LESSENED OVER THE YEARS. THE LEAD MIGRATION WAS AN UNLIKELY CAUSE OF THIS BUT TO EVALUATE ALL REVERSIBLE/POSSIBLE CAUSES THEY WANTED TO GET A BRAIN MRI. THE CAUSE OF THE ISSUE WAS NOT YET DETERMINED. NO ACTIONS HAD BEEN TAKEN THUS FAR. THEY WERE STILL WAITING FOR THE BRAIN MRI. THE ISSUE HAD NOT BEEN RESOLVED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497642 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1