BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7300188 · Received February 27, 2018

    Report

    Report Number
    3007566237-2018-00578
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    January 24, 2018
    Report Date
    March 26, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM, OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389-28, LOT# 0213978211, IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD . PRODUCT ID: NEU_CUSTOM_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE SURGICAL INTERVENTION THAT TOOK PLACE ON (B)(6) 2018 WAS SOLELY FOR THE IMPLANT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) AND EXTENSION. THERE WERE NO ADDITIONAL TROUBLESHOOTING/DIAGNOSTICS OR ACTIONS TAKEN RELATED TO THE HIGH IMPEDANCES, WITH THE ISSUE UNRESOLVED AT THE TIME OF THE REPORT. THERE WERE NO RELATED PATIENT SYMPTOMS AND NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON'S DISEASE. ABNORMAL IMPEDANCES WERE REPORTED. IMPEDANCE MEASUREMENTS ON THE LEFT LEAD WERE NORMAL; HOWEVER, VALUES ON THE RIGHT LEAD WERE HIGH: C/8 AT 2565 OHMS, C/9 AT 2173 OHMS, C/10 AT 2681 OHMS, C/11 AT 2493 OHMS, 8/9 AT 4458 OHMS, 8/10 AT 5201 OHMS, 8/11 AT 4950 OHMS, 9/10 AT 4631 OHMS, 9/11 AT 4631 OHMS, AND 10/11 AT 5090 OHMS. IMPEDANCE CHECK ON RIGHT LEAD WAS RUN AT 0.7 V. IT WAS NOTED THE LEADS WERE IMPLANTED (B)(6) 2018, AND THE INS WAS IMPLANTED (B)(6) 2018. IMPEDANCES WITH NO EXTENSION WERE REPORTED AS 1560 OHMS ON 0/1 (8/9 WHEN CONNECTED TO INS/EXTENSION), 2397 OHMS ON 0/2 (8/10), 2670 OHMS ON 0/3 (8/11), 2784 OHMS ON 1/2 (9/10), AND 4156 OHMS ON 2/3 (10/11). THERE WERE NO X-RAY IMAGES AVAILABLE. ADDITIONAL DIAGNOSTICS/TROUBLESHOOTING AND ACTIONS INCLUDED IMPEDANCE MEASUREMENTS. SURGICAL INTERVENTION WAS PLANNED/SCHEDULED FOR (B)(6) 2018. THERE WERE NO CONTRIBUTING FACTORS THAT LED TO THE ISSUE AND CAUSALITY WAS UNKNOWN. THE ISSUE WAS UNRESOLVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143001 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention