BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3983441 · Received August 6, 2014

    Report

    Report Number
    3007566237-2014-02195
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ANALYSIS OF THE EXTENSION FOUND THAT ¿ALL CONDUCTORS WERE BROKEN 5.2 CM FROM THE PROXIMAL END.¿ ADDITIONALLY IT WAS FOUND THAT ¿ALL SETSCREWS WERE BACKED OUT¿ THOUGH ¿ALL SETSCREWS WERE ABLE TO BE TIGHTENED ONTO A KNOWN GOOD LEAD, CORRECTLY.¿

    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 THE PATIENT EXPERIENCED ¿LESS THAN 50% THERAPY RELIEF¿ AND OVERALL ¿UNEFFECTIVE¿ THERAPY WITH REAPPEARANCE OF THE PATIENT¿S SYMPTOMS ON THEIR RIGHT SIDE BECAUSE THE ¿EXTENSION SCREWS WERE NOT CORRECTLY FIXED WITH THE SCREWS OF THE LEAD.¿ THE SCREW ISSUE WAS SUGGESTED THROUGH X-RAY IMAGES THAT WERE TAKEN OF THE PATIENT¿S DEVICE. RADIOSCOPY THAT WAS PERFORMED ON THE PATIENT WAS ALSO REPORTED TO HAVE INDICATED A ¿DISPLACEMENT OF THE ELECTRODE-EXTENSION CABLE CONNECTION.¿ CONTACT 2 OF THE PATIENT¿S EXTENSION WAS REPORTED TO HAVE BEEN ¿NOT WORKING PROPERLY¿ AND IMPEDANCE TESTING FOUND HIGH IMPEDANCES ¿>40000¿ OHMS ON THE NUMBER 2 ELECTRODE OF THE PATIENT¿S LEFT SUB-THALAMIC NUCLEUS (STN) LEAD. AS A RESULT OF THE ALLEGED ISSUES, IT WAS NOTED THAT SURGICAL INTERVENTION WAS REQUIRED AND THE PATIENT¿S EXTENSION WAS REPLACED. IT WAS STATED THAT THE PATIENT¿S ISSUES WERE RESOLVED AT THE TIME OF REPORT AND THAT THEY WERE ¿RECEIVING EFFECTIVE THERAPY¿ FOLLOWING THE REPLACEMENT OF THEIR EXTENSION. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459286 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention