BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3427825 · Received October 24, 2013

    Report

    Report Number
    3004209178-2013-19616
    Event Type
    Malfunction
    Date Received
    October 24, 2013
    Date of Event
    April 7, 2008
    Report Date
    April 7, 2008
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-1190-2013; Z-0184-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389S-40, LOT# V091844, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DAMAGED #3 CONTACT WAS FOUND WHEN TEMPORARY LEAD COVER WAS REMOVED DURING STAGE TWO SURGERY. IT WAS ADDED THAT DURING THE STAGE TWO PROCEDURE, THE LEFT LEAD WAS REMOVED FROM ITS POCKET. THE END OF THE LEAD WAS COVERED USING THE TEMPORARY COVER WITH THE BOOT. THE RIGHT LEAD HAD ONLY THE COVER AND NO BOOT. WHEN THE DOCTOR TOOK OFF THE TEMPORARY COVER ON THE LEFT SIDE, HE DID FOLLOW THE DIRECTIONS IN REMOVING THE BOOT AND COVER. WHEN HE REMOVED THE COVER, THE #3 CONTACT WAS VISIBLY DAMAGED AND BENT AT 90 DEGREES WITH A FEW FRAYED WIRES EXPOSED. THE DOCTOR WAS ABLE TO FIT THE LEAD INTO THE EXTENSION AND COVER WITH THE BOOT. IMPEDANCE READING WAS NOTED AS NORMAL. IT WAS NOTED THAT THE RIGHT SIDE LEAD END LOOKED NORMAL WHEN THE TEMPORARY COVER WAS REMOVED AND IMPEDANCES WERE ¿GOOD¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547812 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR