BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3971268 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13768
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THE "OUTPUT WAS GOOD IN BIPOLAR MODE. THERE WAS NO OUTPUT FROM CASE IN UNIPOLAR MODE. ALL OUTPUTS TO THE CASE WERE OPEN. UPON VISUAL INSPECTION AFTER MILLING OPEN INS DEVICE, THE CASE BOND WIRE WAS LIFTED ON THE HYBRID SIDE."

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED ¿RELAPSED SYMPTOMS ON THE SIDE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) DUE TO A PROBLEM WITH MONOPOLAR MODE.¿ IT WAS NOTED, THE PATIENT¿S ¿BIPOLAR MODE WAS OK¿ AT THE TIME OF REPORT. IT WAS STATED THAT WHEN THE PATIENT¿S INS WAS CHECKED, THE PATIENT¿S CURRENT AND IMPEDANCE MEASUREMENTS WERE UNDER 7 MICROCAMPS AND OVER 2000 OHMS RESPECTIVELY. IT WAS FURTHER STATED, THE PATIENT¿S EXTENSIONS WERE CHECKED AND WERE FOUND TO BE ¿OK.¿ IT WAS REPORTED THAT AFTER THE PATIENT¿S INS WAS REPLACED ¿THE PATIENT¿S UPDRS (UNIFIED PARKINSON¿S DISEASE RATING SCALE) WAS GOING UP¿ AND THAT THEIR ¿QOL (QUALITY OF LIFE) WAS BETTER THAN BEFORE.¿ IT WAS NOTED THE PATIENT EXPERIENCED ¿NO¿ INJURY OR DEATH AS A RESULT OF THE EVENT AND THAT THEY ¿RECOVERED WITHOUT SEQUELA.¿ A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446708 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention