BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 10839855 · Received November 13, 2020

    Report

    Report Number
    3004209178-2020-19991
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    January 6, 2012
    Report Date
    January 8, 2021
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37612, SERIAL# (B)(6), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 3389S-40, LOT#: V012196, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID: 3389S-40, LOT#: V067514, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED AFTER SURGERY THE PROGRAMMER COULDN¿T FIND A COMBINATION OF SETTINGS (PULSE WIDTH, VOLTAGE, ETC) THAT WOULD STOP OR EVEN REDUCE THEIR TREMORS. ACCORDING TO THE CONSUMER IT ¿TOOK A LONG TIME WITH THE RIGHT SIDE, BUT A MAGICAL COMBINATION WAS FOUND WHICH WASN¿T THE CASE ON THE LEFT SIDE.¿ THE CONSUMER WASN¿T SURE OF THE CAUSE OF THE DEVICE BEING UNABLE TO BE PROGRAMMED TO HELP THEIR SYMPTOMS, BUT THEY SAW A SURGEON MUCH LATER WHO SAID THEY THOUGHT THE PROBE WAS IN THE WRONG PLACE. THE CONSUMER STATED THEY DIDN¿T HAVE ¿NEW IMPLANTS AS THE SAME ONES WERE STILL IN THEIR HEAD, THEY JUST HAD THE BATTERY REMOVED BECAUSE IT WAS A NUISANCE AND IN THE WAY.¿.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED AND THE NEW RECHARGEABLE INS WAS REPLACED BECAUSE THEY COULD NOT PROGRAM IT TO HELP SYMPTOMS. REFER TO MANUFACTURER REPORT #3004209178-2020-19990 FOR RELATED SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303921 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SEE H10