BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7101361 · Received December 8, 2017

    Report

    Report Number
    3004209178-2017-25678
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    December 5, 2017
    Report Date
    October 3, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL # (B)(4)) REVEALED THAT THE BATTERY HAD NORMAL END OF LIFE AND THE TELEMETRY AND OUTPUT WERE OKAY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE INDICATING THAT THEY REPLACED THE BATTERY FOR THE PATIENT ON (B)(6) 2018. PRE-OP IMPEDANCES: BATTERY 2.51V LGPI 3-, C+ 3.9V 90US 160HZ 713 OHMS 5.429MA C/0 3342 C 3.0V C/1 18721 C/2 >40,000 C/3 731 0/1 16042 0/2 40,000 0/3 3577 1/2 >40,000 1/3 16208 2/3 >40,000 RGPI 9-, 11+ 5.6V 90US 160HZ 1363 OHMS 4.154MA C/8 840 0.7V C/9 826 C/10 835 C/11 957 8/9 1044 8/10 1265 8/11 1480 9/10 1036 9/11 1417 10/11 1255 INTRA-OP IMPEDANCES: LGPI 727 OHMS 5.323 RGPI 1393 OHMS 4.068 C/0 777 C/1 744 C/2 714 C/3 728 0/1 969 0/2 1125 0/3 1210 1/2 865 1/3 1067 2/3 817 C/8 794 C/9 800 C/10 798 C/11 947 8/9 1020 8/10 1236 8/11 1461 9/10 1017 9/11 1403 10/11 1232 NO POST-OPERATIVE IMPEDANCES WERE FOUND.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING A NEW LEAD WAS NOT IMPLANTED AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT HAD STIFFENING AND RIGHT SIDE ASYMMETRY, SO THEY WENT TO THE HOSPITAL. THE PATIENT FELT A RETURN OF SYMPTOMS. IMPEDANCES WERE TAKEN THERAPY AND ELECTRODE. THE LEFT GPI STATED HIGH OHMS LOW MA. ELECTRODE IMPEDANCE ALL COMBOS IF 1 <(>&<)> 2 +40,000 OHMS. THE PATIENT WAS REPROGRAMMED ON C+ 3-. THE ISSUE WAS UNRESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880784 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention