BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2847211 · Received November 27, 2012

    Report

    Report Number
    9614453-2012-00230
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 29, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748266, SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID 748251, SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID 3387-28, LOT# V041052, (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

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE, SERIAL #(B)(4), FOUND IT WAS NOT IN NEW CONDITION. THERE WERE NO SIGNIFICANT ANOMALIES. ANALYSIS OF THE EXTENSION, SERIAL #(B)(4), FOUND ALL OF THE CONDUCTORS BROKEN 5.2 CENTIMETERS FROM THE PROXIMAL END.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS WEAKENED THERAPY EFFECT. IT WAS ALSO REPORTED THERE WAS A FRACTURE OF THE EXTENSION. PATIENT CONDITION WAS 'NOT GOOD.' THE HEALTH CARE PROFESSIONAL TRIED STIMULATION ADJUSTMENT WITH NO HELP TO THE SYMPTOMS. IMPEDANCE VALUES APPEARED TO BE NORMAL. THE BATTERY WAS LOW THEREFORE THE HEALTH CARE PROVIDER PLANNED THE REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS). PRIOR TO PROCEDURE AN X-RAY WAS TAKEN AND THE FRACTURE ON THE EXTENSION WAS CONFIRMED. INS AND EXTENSION WERE REPLACED. PATIENT OUTCOME WAS NOT RECOVERED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention