BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4334595 · Received December 16, 2014

    Report

    Report Number
    3004209178-2014-24073
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Report Date
    November 26, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 6 4002, LOT# N242508, IMPLANTED: 2010 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 748966, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387-40, LOT# J0545158V, IMPLANTED: 2005 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION AND A ¿CALL YOUR DOCTOR¿ AND OUT OF REGULATION (OOR) MESSAGE WAS DISPLAYED ON THE PATIENT PROGRAMMER. THE PATIENT HAD A PULSATING FEELING DOWN THE LEFT SIDE. THE PATIENT WAS ABLE TO USE THE PATIENT PROGRAMMER TO TURN STIMULATION DOWN. DUE TO ABNORMAL IMPEDANCES THE PATIENT WAS SCHEDULED FOR AN EXTENSION REPLACEMENT ON 2014 (B)(6). THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS TO BE REPLACED AT THAT TIME DUE TO NORMAL BATTERY DEPLETION. DURING A PRE-SURGERY CONSULT WITH THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP), NO SYSTEM INTEGRITY ISSUES, OPENS OR SHORTS WERE NOTED. FOLLOW UP WITH A MANUFACTURING REPRESENTATIVE INDICATED THE PATIENT¿S SURGERY WAS CANCELLED AS THE SOURCE OF THE ABNORMAL IMPEDANCES WAS DETERMINED TO BE DUE TO A MISS NUMBERING OF THE ELECTRODES. THIS WAS CORRECTED USING A CLINICIAN PROGRAMMER. THE PATIENT WAS SCHEDULED TO SEE THEIR HCP FOR PROGRAMMING IF NEEDED. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822096 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR