BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 6171860 · Received December 13, 2016

    Report

    Report Number
    3004209178-2016-26383
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    January 1, 2016
    Report Date
    July 25, 2017
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCORRECT AWARE DATE WAS SUBMITTED FOR THE ADDITIONAL INFORMATION. AWARE DATE CORRECTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REITERATED THAT THEIR LEFT INS HAS BEEN DEAD FOR A WHILE, ABOUT A YEAR. IT WAS STATED THAT THE HEALTHCARE PROFESSIONAL (HCP) CLAIMS THE INS DEPLETION IS DUE TO A BROKEN WIRE AS OF "A WHILE AGO" WHICH WAS DETERMINED WHEN THE HCP TURNED THE INS OFF. FURTHERMORE, THE RIGHT SIDE INS IS ALSO GOING DEAD AS OF ABOUT 6 MONTHS AGO AND THE PATIENT PROGRAMMER (PP) SHOWS A CALL YOUR DOCTOR SCREEN. IT WAS CONFIRMED THAT THE PATIENT WAS SEEING AN ELECTIVE REPLACEMENT INDICATOR (ERI) CODE, WITH NO DISSATISFACTION TOWARD INS LONGEVITY. HOWEVER, THE PATIENT HAS HAD A CHANGE IN SYMPTOMS OVER THE LAST COUPLE OF MONTHS AS A RESULT, WITH THEIR MEDICATION HELPING BUT WEARING OFF AFTER 2.5 HOURS SO THEY HAVE TO TAKE EXTRA CARBIDOPA. NO FURTHER COMPLICATIONS ARE ANTICIPATED. SEE RELATED REGULATORY REPORT 3004209178-2016-26382.

    Description of Event or Problem · 1

    SEE RELATED REGULATORY REPORT 3004209178-2016-26382.

    Description of Event or Problem · 1

    A FRIEND OR FAMILY MEMBER OF THE PATIENT REPORTED THAT THE PATIENT HAD A LOSS OF THERAPY, AND THAT BOTH IMPLANTABLE NEUROSTIMULATOR (INS) BATTERIES HAVE RUN OUT AS OF A COUPLE OF MONTHS PRIOR TO DATE NOTIFIED. IT WAS STATED THAT THE PATIENT HAS HAD 20 OR 30 FALLS WHICH STARTED HAPPENING EARLIER IN 2016. FOLLOW UP WITH THE HEALTHCARE PROVIDER (HCP) IS TO BE CONDUCTED. THE PATIENT'S INDICATION FOR IMPLANT IS PARKINSON'S DUAL AND MOVEMENT DISORDERS. SEE RELATED REGULATORY REPORT 3004209178-2016-26382.

    Description of Event or Problem · 1

    THE PATIENT LATER REPORTED THAT BOTH INSS HAD BEEN DEAD ABOUT 3-4 MONTHS AND THEIR PHYSICIAN SAID THERE WAS NOTHING THEY COULD DO. THE PATIENT WAS LOOKING AT OTHER DOCTORS TO DISCUSS IF BATTERY REPLACEMENT WAS AN OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822533 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR