BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4132553 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18080
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_WRENCH_ACC, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY; PRODUCT ID NEU_ STIMLOC_ACC, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY; PRODUCT ID 3389S-40, LOT# V603031, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_WRENCH_ACC, PRODUCT TYPE: ACCESSORY. PRODUCT ID NEU_ STIMLOC_ACC, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3389S-40, LOT# V603031, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. ANALYSIS OF THE LEAD FOUND ALL CONDUCTORS WERE BROKEN NEAR THE CONNECTORS WELD SITE (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 WHILE THE DEEP BRAIN STIMULATOR SYSTEM WAS BEING EXPLANTED THE SURGEON HAD MOVED THE LEAD FROM THE BRAIN AND HAD ATTEMPTED TO PULL THE LEAD AND EXTENSIONS OUT BUT THE LEAD HAD FRAYED AT THE LEAD EXTENSION CONNECTION. THE SYSTEM WAS ABLE TO BE EXPLANTED BUT THE SURGEON WAS UNABLE TO TELL IF THE METAL CONTACTS WERE STILL IN THE EXTENSION. AN X-RAY WAS DONE AND HAD NOT REVEALED ANY LEFTOVER MATERIAL IN THE PATIENT. NO ACTION WAS REQUIRED AS A RESULT OF THE EVENT. IT WAS NOTED THAT THE DEVICE WAS BEING EXPLANTED DUE TO AN UNRELATED/UNKNOWN MEDICAL CONDITION THAT WOULD REQUIRE DIAGNOSTIC MRI OF THE SPINE AND BRAIN. THE PATIENT WAS ALIVE WITH NO INJURY AND NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611344 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR