BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4151781 · Received October 8, 2014

    Report

    Report Number
    9614453-2014-02084
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ANALYSIS OF THE PATIENT¿S EXTENSION FOUND ¿THE #1 CONDUCTOR WIRE WAS EXPOSED AT A BREACHED DEPRESSION IN THE OUTER INSULATION 24.3 CM FROM THE DISTAL END. THE #3 CONDUCTOR WIRE WAS EXPOSED AT A BREACHED DEPRESSION IN THE OUTER INSULATION 26.0 CM FROM THE DISTAL END. IT WAS UNKNOWN HOW MUCH WIRE WAS EXPOSED PRIOR TO EXPLANT.¿ ANALYSIS OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO ANOMALIES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT WOULD ¿FALL SOMETIMES.¿ HOWEVER, IT WAS UNKNOWN WHETHER THE PATIENT¿S ISSUES BEGAN FOLLOWING A FALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PARKINSON¿S DISEASE PATIENT EXPERIENCED A BURNING SENSATION AT THEIR DEVICE POCKET. IMPEDANCE TESTING OF THE PATIENT¿S LEFT LEAD FOUND A ¿LOW¿ UNIPOLAR ELECTRODE IMPEDANCE OF 247 OHMS ON ELECTRODE 1 AND LOW BIPOLAR ELECTRODE IMPEDANCES OF 101, 71, AND 87 OHMS ON 0-2, 0-3, AND 2-3 RESPECTIVELY. IMPEDANCE VALUES MEASURED ON THE PATIENT¿S RIGHT LEAD FOUND NO OUT-OF-RANGE VALUES. THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) AND EXTENSION (B)(4) WERE REPLACED AS A RESULT OF THE EVENT. IMPEDANCE TESTING THAT WAS PERFORMED WITH THE PATIENT¿S ORIGINAL INS (B)(4) AND LEAD AND A NEW EXTENSION (B)(4) FOUND THAT BIPOLAR IMPEDANCE PAIR 0-3 CONTINUED TO HAVE A LOW IMPEDANCE OF 70 OHMS. THIS VALUE REMAINED UNCHANGED FOLLOWING THE REPLACEMENT OF THE INS. THE IMPEDANCE OF BIPOLAR ELECTRODE PAIR 0-3 REMAINED 70 OHMS WITH A NEW INS (B)(4), NEW EXTENSION, AND THE ORIGINAL LEAD. IT WAS NOTED THE PATIENT HAD PREVIOUSLY EXPERIENCED ¿SOME FALLS,¿ HOWEVER, NO FURTHER INFORMATION WAS REPORTED REGARDING THIS ISSUE. THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT AND WAS ¿OK¿ AS OF 24 DAYS AFTER INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632749 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention