BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3231437 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11891
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 10, 2013
    Report Date
    September 3, 2013
    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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS OF THE STIMULATOR REVEALED NO SIGNIFICANT ANOMALY FOUND. THE STIMULATOR HAD NORMAL END OF LIFE AND TELEMETRY OUTPUT WAS NOTED AS ¿OKAY.¿ THE STIMULATOR WAS RECEIVED IN EOS CONDITION WITH THE BATTERY VOLTAGE AT 2.88 VOLTS. THE EOS BIT WAS RESET USING THE PROGRAMMER SO OUTPUT COULD BE TESTED. THE STIMULATOR HAD GOOD TELEMETRY AND OUTPUT AND PASSED FINAL FUNCTIONAL TEST ON THE AUTOMATED TEST CONSOLE. THE REPORTED EVENT INFORMATION INDICATED THERE WAS A SHORT IN THE SYSTEM ACROSS ELECTRODES 1 AND 2. THE SESSION HISTORY STORED IN THE STIMULATOR SHOWED ELECTRODE 1 WAS NEGATIVE AND 2 WAS POSITIVE. THE SHORT ACROSS THESE ACTIVE ELECTRODES WOULD CAUSE HIGHER THAN NORMAL LOAF ON THE BATTERY WHICH WOULD HAVE PULLED IT DOWN TO THAT EOS BIT WAS SET. AFTER THE EOS BIT WAS SET THE OUTPUT WAS TURNED OFF AND CANNOT BE TURNED ON. THEREFORE THE LOAD ON THE BATTERY FROM THE SHORT WAS REMOVED AND THIS ALLOWED THE BATTERY TO RECOVER TO 2.88 VOLTS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7495, LOT# NAF006304N, PRODUCT TYPE: EXTENSION, PRODUCT ID: 3387-28, LOT# N22992, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE CAUSE OF THE HIGH/LOW IMPEDANCE WAS MOST LIKELY FRACTURE OF THE LEAD OR EXTENSION, THIS WAS NOT CONFIRMED AS THEY HAD NOT SEEN THE PATIENT YET. THE IMPEDANCE ANOMALIES STILL PERSISTED AFTER REVISION BUT THE ELECTRODE PAIRS WITH THE ANOMALIES WERE NOT USED FOR THERAPY. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN END OF LIFE, END OF SERVICE MESSAGE. PATIENT HAD ONLY HAD THE STIMULATOR FOR ABOUT ONE MONTH AND LONGEVITY SHOWED IT SHOULD LAST FOR LESS THAN 2 YEARS. THE PAST PROGRAMMING WAS NOT KNOWN, NOR STATUS OF THERAPY SINCE IMPLANT. THERAPY IMPEDANCE RANGE WAS NORMAL AT 558 OHMS BUT OTHER PAST IMPEDANCES WERE NOT KNOWN. IT¿S NOT KNOWN IF OTHER X-RAYS HAVE BEEN DONE. THEY REPLACED THE STIMULATOR ON (B)(6) 2013. IT WAS LATER REPORTED THE EOS INDICATION WAS FOUND THOUGH BATTERY VOLTAGE REMAINED AT 2.9 VOLTS. IT WAS NOTED THE DEVICE COULD NOT BE POWERED ON AND THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL. TELEMETRY WAS PERFORMED USING ANOTHER CLINICAL PROGRAMMER. AN EOS MESSAGE WAS FOUND AT THE BEGINNING OF TELEMETRY. ADJUSTMENTS OF PARAMETERS, CHANGE OF STIMULATION INTENSITY AND ELECTRODES IN USE WERE DONE, MEASUREMENT OF IMPEDANCE WAS DONE BUT THE BUTTON FOR SWITCHING ON/OFF POWER COULDN¿T RESPOND. NORMAL IMPEDANCE WAS FOUND IN ALL CONFIGURATIONS OF BIPOLAR, BUT HIGH VALUE PRESENTED A SUSPICION OF FRACTURE WAS FOUND IN ALL MONOPOLAR CONFIGURATIONS. IT WAS DECIDED THAT THE DEVICE WOULD NEED TO BE REPLACED BECAUSE NO STIMULATION WOULD POSE A HEALTH HAZARD TO THE PATIENT. IT WAS REPORTED THERE WERE IMPEDANCES BETWEEN 1 AND 2 THAT SHOWED A SHORT CIRCUIT. ELECTRODE CONFIGURATION WAS CHANGED AND THAT BATTERY VOLTAGE WENT FROM 2.2 VOLTS TO 2.67 VOLTS.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THAT THE AN IMPEDANCE ISSUE HAD BEEN PREVIOUSLY REPORTED IN MANUFACTURER REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331262 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R