BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7903327 · Received September 24, 2018

    Report

    Report Number
    3004209178-2018-21401
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    September 1, 2018
    Report Date
    October 22, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994761057
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) STATING THAT THE PATIENT WAS SCHEDULED FOR LEAD/EXTENSION EXPLORATORY SURGERY TODAY. THE CALLER REPORTED THAT PATIENT HAS BEEN EXPERIENCE RIGHT SIDE SURGES, MULTIPLE TIMES IN A DAY, UNKNOWN AMOUNT, BUT DOZENS/MULTIPLES TIMES A DAY. IT WAS STATED THAT NO MATTER WHAT POSITION PATIENT IS IN, CAN BE SITTING AND SURGES OCCURS. NO X-RAYS WERE DONE. IT WAS NOTED THAT THE SURGES STARTED IN (B)(6) 2018. ELECTRODE IMPEDANCES ARE: C3 826 OHMS C2 1220 OHMS C1 1088 OHMS C0 1538 OHMS 03 1722 OHMS 13 1192 OHMS 23 1023 OHMS 02 1892 OHMS 12 1192 OHMS 01 1358 OHMS IT WAS ALSO REPORTED THAT AT THE LAST APPOINTMENT PATIENT HAD A REPROGRAMMING USING ELECTRODE 1-2+, FURTHER MENTIONING THAT AT THAT TIME, A NEW CONFIGURATION WAS PROGRAMMED: C+1- THERAPY IMPEDANCE: 1030OHM 2.5MA. AND WITH THIS PROGRAMMING THE , PATIENT HAS NOT HAD ANY SURGES. IT WAS STATED THAT THE PHYSICIAN HAS CANCELED THE EXPLORATORY AS PATIENT HAD NO SURGES SINCE THE NEW PROGRAM. THE PHYSICIAN INDICATED THAT IF PATIENT EXPERIENCE SURGES IN THE FUTURE, WILL DO EXPLORATORY OF THE LEAD/EXTENSION.

    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

    CORRECTION TO SHOW FALL CODE . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) INDICATING THAT THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) AND THEY WERE GOING TO INTERROGATE THE LEAD AND REPLACED THE LEAD EXTENDER IF INDICATED. IT WAS ALSO REPORTED THAT PATIENT HAD A SHORT CIRCUIT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON¿S DUAL, MOVEMENT DISORDERS. IT WAS REPORTED THAT THE NURSE HAD SEEN OOR ON THE PATIENT¿S PROGRAMMER. THE CALLER WAS ALSO REPORTING SHOCKING/SURGES OF ELECTRICAL STIMULATION. THEY REPORTED THE RIGHT INS WAS PROGRAMMED 1- 2+ AND THE PATIENT WAS EXPERIENCING INTERMITTENT SHOCKING SENSATIONS AND OOR. THERAPY IMPEDANCE WAS 721 OHMS 7.6 MA. IT WAS REPORTED THAT THE PATIENT FALLS MULTIPLE TIMES PER DAY. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741728 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602 00613994761057

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention