BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 4203714 · Received October 27, 2014

    Report

    Report Number
    9614453-2014-02568
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    November 6, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALY. THE INS WAS AT NORMAL END OF LIFE AND THERE WAS NO TELEMETRY OR OUTPUT. THIS INS WAS RECEIVED WITH NO TELEMETRY AND NO OUTPUT. DESTRUCTIVE ANALYSIS OF THE INS SHOWED THAT THE BATTERY WAS DEPLETED. NO ELECTRICAL ANOMALIES WERE FOUND WITH THE HYBRID CIRCUIT THAT WOULD HAVE CAUSED PREMATURE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THAT PRIOR TO THE REPLACEMENT, THE PATIENT HAD BEEN PROGRAMMED TO A PULSE WIDTH OF 210 MICROS AND A RATE OF 50 HZ. THE AMPLITUDE AND IMPEDANCE MEASUREMENTS COULD NOT BE OBTAINED. IT WAS LATER STATED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY FOLLOWING THE EXPLANT. THE PATIENT¿S DEVICE WAS REPLACED WITH A RECHARGEABLE DEVICE SINCE MONOPOLAR STIMULATION WAS DESIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) FAILED AND PREMATURELY DEPLETED. THE INS HAD DEPLETED AHEAD OF EXPECTATION SO THE INS WAS EXPLANTED AND REPLACED. THE PATIENT HAD LOST STIMULATION AS A RESULT OF THE BATTERY DEPLETION. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. NO OUTCOME WAS 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
    682871 ITREL 3 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention