BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3925618 · Received July 10, 2014

    Report

    Report Number
    3007566237-2014-01920
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3389S-40, LOT# VA0J73R, IMPLANTED: (B)(6) 2014. PRODUCT TYPE: LEAD. PRODUCT ID: NEU_U NKNOWN_EXT. LOT# SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DAMAGE WAS DETECTED WHEN THE LEAD WAS REMOVED. IT WAS STATED SURGICAL INTERVENTION OCCURRED AND THE CONTACT WAS CUT OFF. IMPEDANCE TESTING WAS PERFORMED AND THE CAUSE OF THE ISSUE WAS DETERMINED. THE TEMPORARY COVER ON THE LEAD WAS PULLED TOO HARD DURING THE EXPOSURE IN STAGE 2 AND THE LEAD WAS DAMAGED. IT WAS STATED THE #3 CONTACT WAS CUT OFF IN ORDER TO CONNECT THE LEADS TO THE EXTENSION. THE INNER CONTACT DISTANCE BETWEEN 2 AND 3 STRETCHED TO ABOUT 5 INCHES AND THE WIRES WERE EXPOSED. THE EXCESS WIRE AND CONTACT 3 WAS CUT OFF IN ORDER TO BE ABLE TO MAKE THE CONNECTION. ONCE IT WAS CONNECTED, THE IMPEDANCES REVEALED AN OPEN CIRCUIT WITH 3 BUT THE REMAINING CONTACTS READ NORMAL. THE PATIENT STATUS AT THE TIME OF REPORT AS ALIVE WITH NO INJURY AND IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS. THE PATIENT HAD NOT BEEN PROGRAMMED YET AND THEY DID NOT KNOW IF THE IMPEDANCES WOULD REMAIN OK FOR THE REMAINING CONTACTS. IT WAS FURTHER REPORTED THE IMPEDANCE ISSUE OCCURRED DURING STAGE II WITH THE CONNECTION OF LEAD TO THE EXTENSION. THE PATIENT WAS ASLEEP. IT WAS NOTED THE IMPEDANCE MEASUREMENTS WERE >40,000OHMS FOR ALL CONTACTS INCLUDING 3 AND THE REMAINDER WERE IN NORMAL RANGE. THE HIGH IMPEDANCES DID NOT RESOLVE AND THE LEAD COULD NOT BE REPAIRED BEYOND WORKING WITH AS IS. NO NEW INFORMATION WAS REPORTED; THE PATIENT WAS TO BE SEEN BY THEIR NEUROLOGIST IN THE MONTH OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404175 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention