BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 4243720 · Received November 11, 2014

    Report

    Report Number
    3007566237-2014-03295
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 7, 2014
    Report Date
    January 2, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3387-40, LOT# 0208412703, IMPLANTED: 2014-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3387-40, LOT# 0208208698, IMPLANTED: 2014-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3387-40, LOT# 0208222358, IMPLANTED: 2014-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3387-40, LOT# 0208378748, IMPLANTED: 2014-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3387-40, LOT# 0208413226, IMPLANTED: 2014-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_STYLET_ACC, PRODUCT TYPE: ACCESSORY. ANALYSIS OF THE LEAD FOUND NO ANOMALY. THE LEAD WAS TESTED WITH A KNOWN GOOD SCREENING CABLE. THE SCREENING CABLE WAS CONNECTED TO AN EXTERNAL NEUROSTIMULATOR (ENS), WHILE THE DISTAL END OF THE LEAD WAS PLACED IN 0.9% SALINE SOLUTION. USING A CLINICIAN PROGRAMMER, NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS AND ELECTRODE PAIR COMBINATIONS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE DEFECTIVE LEAD WAS THE LEAD WHICH WAS RETURNED AND PREVIOUSLY ANALYZED. THE "BAD" IMPEDANCES RESOLVED AFTER REPLACING THE LEAD. IT WAS UNKNOWN IF THE PATIENT WAS GETTING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS "OK".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A PROCEDURE WHERE 4 LEADS WERE IMPLANTED, ONE OF THE LEADS WAS DEFECTIVE; IMPEDANCE WAS MEASURED AND REVEALED TO BE ¿BAD¿. IT WAS UNKNOWN IF IT WAS ¿TOO HIGH OR TOO LOW¿. THE LEAD WAS SUBSEQUENTLY REPLACED. IT WAS NOT POSSIBLE TO DETERMINE WHICH LOT NUMBER CORRESPONDED TO THE DEFECTIVE LEAD. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727318 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR