BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4780508 · Received May 19, 2015

    Report

    Report Number
    3007566237-2015-01351
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3387S-40, LOT# VA0BBQP, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# VA0BBQP, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES WERE MEASURED PRE OPERATION. THE FOLLOWING IMPEDANCES WERE MEASURED: C-2 = 21769, 0-2 = 21619, 1-2 = 21619, AND 2-3 = 19111 OHMS. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED, BUT HIGH IMPEDANCES GREATER THAN 40,000 OHMS WERE MEASURED WITH THE NEW INS. THE PATIENT DID NOT USE CONTACT TWO SO THE HEALTHCARE PROFESSIONAL (HCP) DECIDED TO PROGRAM AROUND THE CONTACT. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP ISBEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. REFER TO MANUFACTURER REPORT #3004209178-2015-09337.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324510 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR