BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7331603 · Received March 12, 2018

    Report

    Report Number
    3004209178-2018-04861
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    March 8, 2018
    Report Date
    March 27, 2018
    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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID B)(4) LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID (B)(4) LOT# V191279 SERIAL# IMPLANTED: (B)(6) 2009 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID (B)(4) LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID (B)(4) LOT# V191279 SERIAL# IMPLANTED: (B)(4)2009 EXPLANTED: PRODUCT TYPE LEAD IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V191279, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V191279, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 7482A51, SERIAL/LOT #: (B)(4), UBD: (B)(6) 2012, ; PRODUCT ID: 3387S-40, SERIAL/LOT #: V191279, UBD: (B)(6) 2012, ; PRODUCT ID: 7482A51, SERIAL/LOT #: (B)(4), UBD: (B)(6) 2012, ; PRODUCT ID: 3387S-40, SERIAL/LOT #: V191279, UBD: (B)(6) 2012. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP VIA THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THE CAUSE OF THE OUT OF RANGE IMPEDANCES WAS NOT DETERMINED. NO ACTIONS/INTERVENTIONS WERE TAKEN AND THE ISSUE WAS NOT RESOLVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR. IT WAS REPORTED DURING A DEVICE FOLLOW UP APPOINTMENT SOME ELECTRODES WERE OUT OF RANGE AND HAD ELECTRODE IMPEDANCES AT 3.0 V. C<(>&<)> 0 WAS 2683 OHMS. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS WERE THOUGHT TO HAVE LED OR CONTRIBUTED TO THE ISSUE. THE ISSUE AS NOT RESOLVED AT THE TIME OF THE REPORT. SURGICAL INTERVENTION DID NOT OCCUR AND IT WAS UNKNOWN IF IT WAS PLANNED. THE PATIENT WAS ALIVE WITHOUT INJURY AT THE TIME OF THE REPORT. NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174103 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR