BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6110149 · Received November 17, 2016

    Report

    Report Number
    2649622-2016-13869
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 28, 2016
    Report Date
    September 28, 2018
    Manufacturer
    MPRI
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD FOUND CONDUCTOR CROSSOVER OF THE CONDUCTOR ON THE PROXIMAL END OF THE LEAD. THE LEAD WAS RECEIVED WITH THE STYLET INSERTED AND CIRCUITS #1 AND #2 WERE INTERMITTENTLY SHORTED. CIRCUITS #1 AND #2 WERE STILL SHORTED WITH THE STYLET REMOVED. WHEN MEASURED AT THE PROXIMAL END, IMPEDANCES BETWEEN CIRCUITS #1 AND #2 VARIED FROM 1 OHMS TO OPEN WHEN THE LEAD IS SLIGHTLY FLEXED AT THE #2 CONTACT. THE LEAD ALSO FAILED IMPEDANCE TEST IN SALINE AT CHECK-IN. X-RAY PICTURE INDICATES CONDUCTOR CROSS-OVER UNDER THE #1 CONTACT. RECENT FDA CODING CHANGES OFFER LIMITED OPTIONS FOR MEDICAL DEVICE EVALUATION CONCLUSION CODING. MEDTRONIC SELECTED CONCLUSION CODE BECAUSE THIS IS THE CLOSEST CODE AVAILABLE WITH RESPECT TO THIS EVENT. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_STYLET_ACC, PRODUCT TYPE: ACCESSORY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT WHEN THE PATIENT'S ELECTRODES WERE IMPLANTED, THE ELECTRODE IMPEDANCES WERE ABNORMAL. FOLLOWING TROUBLESHOOTING THE IMPEDANCES WERE STILL ABNORMAL SO THE ELECTRODE WAS REPLACED. THE PATIENT'S INDICATION FOR IMPLANT IS PARKINSON'S DUAL AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760644 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MPRI 3389S-40 VA131L7

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention