BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2769373 · Received October 2, 2012

    Report

    Report Number
    3004209178-2012-08811
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Report Date
    September 4, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3387S-40, LOT# V129475, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED LOSS OF THERAPEUTIC EFFECT. THERE WAS LACK OF THERAPY OR SYMPTOM CONTROL ON LEFT SIDE OF PATIENT'S BODY FOR THE RIGHT SIDE NEUROSTIMULATOR. OUT-OF-REGULATION (OOR) MESSAGE WAS SEEN. PATIENT WAS IN VOLTAGE MODE. PRIOR TO NEUROSTIMULATOR REPLACEMENT, PATIENT HAD GREAT THERAPY AND TREMOR CONTROL. SINCE REPLACEMENT, PATIENT HAD 3 OR 4 OCCURRENCES OF TINGLING OR NUMBNESS IN LEFT ARMS. THE TINGLING OR NUMBNESS ONLY OCCURRED SINCE REPLACEMENT WITH CURRENT DEVICE. LEFT NEUROSTIMULATOR WAS NORMAL AFTER REPLACEMENT. CURRENT IMPEDANCE MEASUREMENTS WERE HIGH (C0 1316, C1 16286, C2 1058, C3 1089 01 16286, 02 1734, 03 1802, 12 11368, 13 11368, 23 1549). PATIENT WAS PROGRAMMED AT 1.7V, 60US, 145HZ, C+, 1-. THESE VALUES WERE EXACTLY SAME AS THE VALUE READ FROM PREVIOUS DEVICE. IT WAS SUSPECTED THAT THERE WAS FLUID IN THE CONNECTOR BLOCK THAT CAUSED OOR, BECAUSE 1 AND 2, 1 AND 3 PAIRS HAD EXACTLY SAME IMPEDANCE VALUE. TWELVE AND 13 WERE EXACTLY THE SAME IMPEDANCE ALSO. PALPATING DID NOT CAUSE STIMULATION TO CHANGE. THE PHYSICIAN DECIDED TO CHANGE THE ELECTRODE COMBINATION FROM CASE + AND > 1- TO 2+ AND 1- WHICH SEEMED TO HAVE RESOLVED THE ISSUE. IT WAS LATER REPORTED THAT LOW, OUT OF RANGE IMPEDANCE VALUES WERE READ (0/2 AT 9 OHMS). REPROGRAMMING OF C+/2- WAS DONE AND IT WAS AT 657 OHMS. FOLLOW-UP INFORMATION NOTED THAT CAUSE OF EVENT WAS NOT DETERMINED AND NO INTERVENTIONS WERE DONE. PHYSICIAN DID NOT CHANGE THE SETTINGS. THE ORIGINAL SETTINGS WERE C+/2-.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1