BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3203571 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-11215
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7438 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 389-40 LOT# J0114191V, IMPLANTED: 2004 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 748240 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3389-40 LOT# J0124596V, IMPLANTED: 2004 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 748240 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS SCHEDULED FOR REPLACEMENT (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD A RETURN OF SYMPTOMS THE MORNING OF THIS REPORT AND COULD NOT MOVE. THE PATIENT WAS FEELING ¿OFF A LITTLE BIT.¿ THE PATIENT THOUGHT THE DEVICE WAS ON. THERE WAS NO KNOWN ACCIDENT RELATED TO THE EVENT. IT WAS NOTED THAT 3 TO 4 DAYS PRIOR TO THIS REPORT THE PATIENT¿S DEVICES WERE CHECKED WITH THE CLINICIAN PROGRAMMER, NO INFORMATION WAS GIVEN TO THE PATIENT. WHEN THE PATIENT CHECKED DEVICES WITH THE PATIENT PROGRAMMER, THE LEFT ONE HAD THREE GREEN LIGHTS AND A BEEP WHILE THE RIGHT ONLY HAD ONE GREEN LIGHT. THE PATIENT PROGRAMMER WAS NOT COMMUNICATING WITH THE RIGHT SIDE DEVICE. LAST TIME PATIENT USED THE PATIENT PROGRAMMER WAS ¿A LONG TIME AGO.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED FOR BATTERY REPLACEMENTS. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304150 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention