BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2983397 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03168
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3389S-40, LOT# V043266, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3389S-40, LOT# V043266, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED IT WAS AT "NORMAL END OF LIFE" AND HAD "NO TELEMETRY AND NO OUTPUT." FINAL ANALYSIS OF THE EXTENSION REVEALED "THE PROXIMAL END CONNECTOR LEGS WERE SEVERELY STRETCHED. ALL CONDUCTORS WERE SHORTED (OVER STRESS/DAMAGE). THE #2 AND 3 CONDUCTORS WERE BROKE AT THE EDGE OF THE MOLDED RUBBER (OVERSTRESS/DAMAGE).

    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 THAT AN EXTENSION WAS "FRAYED" AT THE HEADER BOX AND "OBVIOUSLY COMPROMISED." IT WAS STATED THAT THE HEALTHCARE PROVIDER WAS IN THE PROCESS OF REPLACING THE IMPLANTABLE NEUROSTIMULATOR WHEN HE FOUND THE FRAYED EXTENSION. THE EXTENSION WAS REPLACED AND RETURNED TO THE MANUFACTURER. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85957 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention