BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8012370 · Received October 28, 2018

    Report

    Report Number
    3004209178-2018-24072
    Event Type
    Malfunction
    Date Received
    October 28, 2018
    Date of Event
    October 9, 2018
    Report Date
    November 30, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389-28, SERIAL/LOT #: (B)(4), PRODUCT ID: 3389-28, SERIAL/LOT #: (B)(4). 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

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389-28. 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

    REPORT TYPE CORRECTED TO MALFUNCTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE LEAD LOT NUMBERS WERE UPDATED AND THE IMPLANT DATES. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE NEUROSURGEON WAS UNHAPPY WITH THE NEW IMPEDANCE CHECKING SYSTEM WITHIN THE NEW TABLET SYSTEM. THERE WAS LOW IMPEDANCE INDICATED ON ELECTRODES 8 AND 9. THERE WAS NO LCC/FAST OPTION TO CHECK THE CONNECTION. THE NEUROSURGEON WAS KEEN TO FINISH THE PROCEDURE; THE SYSTEM CHECK WAS NEW TO THEM AND THEY "DIDN'T TRUST" THE NEW SYSTEM. ONE OF THE LEADS WAS BENT AS THE DOCTOR WAS INSERTING INTO THE IPG, ALTHOUGH THEY WERE NOT 100% WHETHER IT WAS 0-7 OR 8-15. THE DOCTOR CHECKED THE CONNECTION IN THE 8-15 CHANNEL AT THE LEAD (SKULL) END OF THE CIRCUIT, BY UNDOING THE SUTURE, REMOVING THE BOOT AND CHECKING THE CONNECTIONS. THIS DID NOT RESOLVE THE ISSUE WHEN THE IMPEDANCES WERE REMEASURED. THE NVISION WAS USED TO CHECK THE IMPEDANCES/LEAD AND IT SHOWED THE SAME ISSUE. THE SURGEON WAS HAPPY WITH THE NVISION RESULT AND ACCEPTED THE READINGS, INCLUDING THE LOW IMPEDANCE READING AT ELECTRODES 8 AND 9. THE ELECTRODES WERE AS FOLLOWS: LEFT GPI: MONOPOLAR: 3: 815 2: 893 1: 1,000 0: 893 BIPOLAR: 3,0: 1,607 3,1: 1,692 3, 2: 1,334 2, 0: 1,607 2, 1: 1,557 0, 1: 1546 RIGHT GPI: MONOPOLAR: 11: HIGH 10: HIGH 9: 912 8: 853 BIPOLAR: 11,8: HIGH 11,9: HIGH 11,10: HIGH 10,8: HIGH 10,9: HIGH 9,8: 1,465.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) INDICATED THE SURGEON SAID THAT THE LEAD DID NOT BEND DURING INSERTION - THUS ALLEGING IT WAS AN OUT OF BOX ISSUE. THE REP STATED THEY HAD WITNESSED THE LEAD BEND AND BE RE-STRAIGHTENED DURING IMPLANT. THE CAUSE OF THE HIGH AND LOW IMPEDANCES REMAINED UNKNOWN.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853054 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention