BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2425326 · Received January 23, 2012

    Report

    Report Number
    3004209178-2012-00429
    Event Type
    Injury
    Date Received
    January 23, 2012
    Date of Event
    November 14, 2011
    Report Date
    September 22, 2016
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL # 3387-40 LOT # V003964 IMPLANTED (B)(6) 2006 EXPLANTED (B)(6) 2012; EXTENSION MODEL # 748240 LOT # NHU120403V IMPLANTED (B)(6) 2006 EXPLANTED (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM, OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# V003964, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT; THE PATIENT HAD TINGLING FROM SHOULDER TO FINGERS IN THE RIGHT ARM. HE STATES HE HAS HAD THIS FEELING BEFORE IF STIM IS SHUT OFF. THE PATIENT ALSO HAD QUESTIONS RELATED TO THE PATIENT PROGRAMMER AND THE CONTROL MAGNET. IN LATER REPORTING IT WAS NOTED THAT THE PATIENT WAS GOING TO THE HOSPITAL ON (B)(6) 2012 TO "REPAIR THE WIRES." THE DEVICE TRACKING SYSTEM NOTED A REVISION SURGERY ON (B)(6) 2012. THE PATIENT NOTED THEY HAD RECEIVED ASSISTANCE FROM THEIR PHYSICIAN OR THE MANUFACTURER'S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT. IT WAS REPORTED THAT THE WIRES WERE REPLACED IN 2013 BECAUSE THEY WERE ROTTED. NO OTHER INFORMATION WAS PROVIDED.

    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 75 YR Required Intervention