BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 2900930 · Received January 8, 2013

    Report

    Report Number
    3007566237-2013-00069
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE LEAD REVEALED NO ANOMALY FOUND. FINAL ANALYSIS OF THE SCREENING CABLE ACCESSORY REVEALED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_STYLET_ACC, PRODUCT TYPE: ACCESSORY. ADDITIONAL ANALYSIS OF THE UNKNOWN STYLET FOUND THE WIRE¿S PARYLENE COATING DAMAGED AT THE DEPTH STOP SITE. A SHORT WAS OBSERVED IN THE FIELD AND WAS UNABLE TO BE DUPLICATED IN THE LAB; HOWEVER THERE WAS VISIBLE DEPTH STOP DAMAGE ON THE LEAD AND/OR STYLET.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD FOUND THAT THE LEAD BODY CONDUCTOR HAD A SHORT BETWEEN CIRCUITS (OVERSTRESSED/DAMAGED) AT DEPTH STOP SITE. IT WAS NOTED THAT THE SPACING VISUAL FOR THE CONNECTOR AND ELECTRODE END WAS ACCEPTABLE ON BOTH ENDS. IT WAS NOTED THAT THERE WAS DEPTH STOP DAMAGE ON THE LEAD AND STYLET. IT WAS NOTED ¿NO SHORTS (DRY).¿ ANALYSIS FOUND NO ANOMALY WITH THE SCREENING DEVICE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 3550-03, LOT#: UNKNOWN, PRODUCT TYPE: SCREENING DEVICE; PRODUCT ID: 3387S, LOT#: VA00DD1, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE LEAD WAS HOOKED UP TO THE TWIST CABLE, THEY WEREN'T GETTING ANY RESPONSE FROM THE PATIENT. FOUR OR FIVE DIFFERENT LOCATIONS WERE TRIED WILL NO SUCCESS. IT WAS NOTED THAT THERE WAS NO RESPONSE WITH EITHER CABLE. THE REPORTER STATED THAT AN EXTERNAL STIMULATOR WAS HOOKED UP TO THE CLINICIAN PROGRAMMER TO CHECK THE IMPEDANCE OF THE LEAD INTRAOPERATIVELY. IT WAS REPORTED THAT ALL IMPEDANCES WERE LOW, AROUND 9 OR 10 OHMS. IT WAS DETERMINED THAT THE LEAD WAS "NOT OPERABLE" AND PROBABLY "NOT GOOD". THE LEAD WAS REMOVED AND A DIFFERENT LEAD WAS IMPLANTED AND TESTED. EVERYTHING WAS FINE WITH THE NEW LEAD. IT WAS FURTHER REPORTED THAT THE NEW LEAD WORKED PROPERLY AND THE PATIENT RECEIVED APPROPRIATE THERAPY. THERE WAS NO PATIENT INJURY, AND THE PATIENT RECOVERED WITHOUT SEQUELA. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8626 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR