BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2541763 · Received April 19, 2012

    Report

    Report Number
    3004209178-2012-02509
    Event Type
    Injury
    Date Received
    April 19, 2012
    Report Date
    March 27, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL: 3387S-40, LOT#: V031488, IMPLANTED: 2007 (B)(6), EXPLANTED: NA. EXTENSION: MODEL 7482A51, SERIAL#: (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: NA. PROGRAMMER: MODEL 7438 SERIAL#: (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "BUZZING" IN HER HEAD THAT WENT AWAY AFTER THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF. SHE ALSO FELT NUMBNESS IN HER FACE. THE PATIENT WENT EMERGENCY ROOM. NO FALLS OR INJURIES WERE NOTED TO CORRESPOND WITH THE SYMPTOMS. IT WAS ALSO NOTED THAT THE PATIENT WAS GOING TO HAVE THE INS REPLACED NEXT WEEK. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THE INS REPLACED ON (B)(6) 2012. AFTER REPLACEMENT THERE WAS NO REPORT OF SYMPTOMS. A CT SCAN WAS PERFORMED ON (B)(6) 2012 AND RESULTS WERE NEGATIVE. THE INS REPLACEMENT WAS SCHEDULED PRIOR TO THE REPORTED EVENT DUE TO END OF LIFE OF THE BATTERY.

    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 PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4)