BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 5188072 · Received October 29, 2015

    Report

    Report Number
    9614453-2015-02686
    Event Type
    Injury
    Date Received
    October 29, 2015
    Report Date
    October 6, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7482, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2015, 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

    DEVICE EVALUATION: ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALIES. IT WAS NOTED THE INS BATTERY WAS ¿NOT IN NEW CONDITION.¿ ANALYSIS OF THE EXTENSION FOUND NO SIGNIFICANT ANOMALIES. IT WAS NOTED THE EXTENSION WAS CUT THROUGH AND SEGMENTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURING REPRESENTATIVE THAT IN 2014 THE PATIENT HAD LESS DEEP BRAIN STIMULATION (DBS) EFFECT. RECENTLY A FRACTURE IN THE SYSTEM WAS SUSPECTED DUE TO UNSTABLE IMPEDANCES. ABNORMAL IMPEDANCES WERE MEASURED AND PRIOR TO THE REVISION, IMPEDANCES OF ELECTRODE THREE ON THE LEFT SIDE WAS UNSTABLE. THE IMPEDANCES VALUES IMPLIED A SHORT OR A FRACTURE. THERE WERE NO SUSPICIOUS FINDINGS ON X-RAYS. A REVISION TO REPLACE THE EXTENSION AND IMPLANTABLE NEUROSTIMULATOR (INS) WAS DONE. DURING THE REVISION, BLOOD WAS FOUND TO BE MIXED IN THE UPPER PORTION OF THE INS WERE ELECTRODES 0-3 WERE LOCATED AND ONLY A HALF OF THE BOOT WAS COVERING THE LEAD AND ADAPTOR. AFTER THE REVISION, IMPEDANCES OF ELECTRODE ZERO WERE MEASURED TO BE HIGH. THE CAUSE OF THE HIGH IMPEDANCES, NO INTERVENTIONS, AND 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
    719091 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention