BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3897093 · Received June 26, 2014

    Report

    Report Number
    3007566237-2014-01793
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    June 4, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND "THE INS WAS RECEIVED WITH THE ERI BIT SET. THE BATTERY HAD RECOVERED SOME (2.825 VOLTS WHEN TESTED ON THE TEST CONSOLE) AFTER THE OUTPUT HAD BEEN TURNED OFF AND THE INS DID NOT HAVE A LOAD ON IT. A LONGEVITY ESTIMATE WAS DONE BASED ON THE PARAMETER HISTORY TAKEN FROM THE INS WHEN IT WAS RECEIVED FOR ANALYSIS. THE PARAMETERS WERE FROM THE OLDEST RECORD OF (B)(4) 2014. THE IMPEDANCES WERE TAKEN FROM THE MEASUREMENTS SHOWN ON THE RETURNED PRINTOUT OF (B)(4) 2014. THE LONGEVITY ESTIMATE WAS 2 YEARS TO ERI AND 2.25 YEARS TO EOS. ACCORDING TO THE TRACE REPORT TAKEN FROM THE INS, THE BATTERY DEPLETED TO ERI IN 2.1 YEARS." THE INS WAS FOUND TO HAVE REACHED ¿NORMAL END OF LIFE¿ WITH OKAY TELEMETRY AND OUTPUT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THAT TO THE PHYSICIAN AND PATIENT¿S KNOWLEDGE, NO EVENTS HAD OCCURRED FOLLOWING THE REPROGRAMMING SESSION THAT WOULD HAVE AFFECTED THE SYSTEM. IT WAS REPORTED ¿THE PATIENT WAS DOING WELL AND HE WAS RECEIVING AN EFFECTIVE THERAPY¿ AT THE TIME OF REPORT. IT WAS STATED THE PATIENT WAS ¿PROBABLY¿ GOING TO UNDERGO THE REPLACEMENT PROCEDURE DURING THE WEEK OF FOLLOW-UP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT REPLACEMENT WOULD BE DONE AT THE END OF THE WEEK OF FOLLOW-UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD ¿EXPERIENCED DYSKINESIAS¿ THE WEEK PRIOR TO REPORT. IT WAS STATED THE PATIENT¿S PHYSICIAN ¿SUSPECTED OVERSTIMULATION AND SO CHANGED THE PARAMETERS¿ FROM 3 VOLTS AT 180 HZ AND 210 MICROSEC TO 2 VOLTS AT 130 HZ AND 60 MICROSEC. IT WAS FURTHER STATED THE PATIENT¿S ¿SYMPTOMS IMPROVED AFTER REPROGRAMMING.¿ IT WAS NOTED THAT A X-RAY TEST OF THE SYSTEM AND IMPEDANCE TESTING ¿SHOWED NO ISSUES.¿ IT WAS THEN REPORTED THE PATIENT CAME BACK TO THEIR PHYSICIAN DURING THE WEEK OF REPORT BECAUSE AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE HAD SHOWN UP ON THEIR PATIENT PROGRAMMER WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) AT 2.8 VOLTS. IT WAS NOTED THE PHYSICIAN PROGRAMMER WAS REPORTED TO HAVE SHOWED AN OUT OF RANGE (OOR) MESSAGE AT THAT TIME. IT WAS REPORTED THE PATIENT WAS ¿UNABLE TO ADJUST STIMULATION¿ AT THE TIME OF REPORT. IT WAS STATED THAT IT HAD BEEN PLANNED BUT NOT YET UNDERTAKEN TO REPLACE THE PATIENT¿S INS AS A RESULT OF THE EVENT. IT WAS NOTED THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE 쐁TIENT WAS DOING WELL�OLLOWING THE REPLACEMENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374674 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention