BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 9688152 · Received February 10, 2020

    Report

    Report Number
    3004209178-2020-02936
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    February 6, 2020
    Report Date
    February 24, 2020
    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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 64002, LOT#: N211512, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: ADAPTER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 64002, SERIAL/LOT #: (B)(4), UBD: 22-JUN-2013, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE : PRODUCT ID 64002, LOT# N211512, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2020. PRODUCT TYPE ADAPTER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT'S PRE-OP IMPEDANCE TEST WAS OUT OF RANGE AT BIPOLAR COMBINATION 2<(>&<)>3 ON THE RIGHT SIDE. THE SESSION REPORT SHOWED THAT 2<(>&<)>3 HAD LOW IMPEDANCES OF 79 OHMS. THE IMPEDANCE TEST WAS RUN AGAIN BUT HAD THE SAME RESULTS. THE PATIENT DID NOT REPORT ANY SYMPTOMS OR NOTICEABLE CHANGES IN THERAPY. THE PATIENT'S WIFE NOTED THAT HE HAD FALLEN A FEW TIMES IN THE LAST MONTHS. AFTER THE GENERATOR WAS REPLACED, THE IMPEDANCES WERE STILL LOW AT COMBINATION 2 <(>&<)>3 ON THE RIGHT SIDE. THE REP RECOMMENDED REPLACING THE POCKET ADAPTOR. THE POCKET ADAPTOR WAS CHANGED AND ALL IMPEDANCES WERE NOTED AS NORMAL ON BOTH SIDES AT ALL COMBINATIONS. THE ISSUE WAS SOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) STATING THAT THE PATIENT FALLS OFTEN DUE TO PROGRESSING PARKINSON'S DISEASE. IT WAS INDICATED THAT THE REASON FOR THE INTERVENTION WAS DUE TO NORMAL BATTERY DEPLETION. THE REP ALSO MENTIONED THAT THE CAUSE OF THE LOW IMPEDANCES WAS DETERMINED BECAUSE ONCE THE POCKET ADAPTOR WAS REPLACED, IMPEDANCES WERE NORMAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152100 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR