BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2760785 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-08545
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 10, 2012
    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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL # (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3389-40, LOT # J0327094V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3389-40, LOT # J0322218V, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SURGING SENSATION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET, EXTENSION LOCATION, AND UP THE RIGHT SIDE OF THE NECK. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS EVENT. THE SURGING SENSATION STARTED 2 DAYS AGO AFTER SHE ROTATED HER HEAD AND NECK. IT WAS ALSO NOTED THAT THE INS WAS TILTED IN THE POCKET AND WASN'T POSITIONED THE SAME AS THE LEFT INS. THE RIGHT INS HAD A HISTORY FOR THE PAST 2 YEARS OF MOVING AROUND IN THE POCKET. THE ELECTRODE IMPEDANCES WERE NORMAL; NOTHING "LOOKED" OUT OF RANGE. THE HEALTH CARE PROFESSIONAL (HCP) PLANNED TO ORDER AN X-RAY, BUT THE DATE WAS UNKNOWN AT THE TIME OF THIS REPORT. THE PATIENT STATUS WAS NOTED AS FAIR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE FIRST HEALTH CARE PROVIDER (HCP) ON (B)(6) 2012 REPORTED THAT THE CAUSE OF THE EVENT WAS IMPLANTABLE NEUROSTIMULATOR (INS) END OF BATTERY LIFE. IT WAS NOTED THAT THE BATTERY PACK WAS "MOVING AROUND" AND NEEDED TO BE TACKED DOWN. IT WAS STATED THAT THE "MOVING AROUND" ISSUE WAS ADDRESSED BY A BILATERAL INS REPLACEMENT, WHICH REQUIRED HOSPITALIZATION FOR BATTERY REPLACEMENT DUE TO END OF LIFE. THE PATIENT OUTCOME WAS NO INJURY. ADDITIONAL INFORMATION RECEIVED FROM THE SECOND HCP ON (B)(6) 2012 REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THAT THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS, AND A REPLACEMENT SURGERY WAS SCHEDULED FOR (B)(6) 2012. IT WAS STATED THAT THE SIGNS AND SYMPTOMS ASSOCIATED WITH THE EVENT INCLUDED TINGLING AND MOVEMENT OF BATTERY PACK. THE PATIENT OUTCOME WAS NO INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention