BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 8522542 · Received April 17, 2019

    Report

    Report Number
    3004209178-2019-07605
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    May 15, 2013
    Report Date
    April 17, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994934604
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 3387S-40, LOT# V931137, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #:(B)(4), UBD: 27-SEP-2014, UDI#: (B)(4). SEE REGULATORY REPORT# 3007566237-2013-02315 FOR OTHER IMPLANTABLE NEUROSTIMULATOR INVOLVED IN THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TURNED OVER IN BED THAT NIGHT AND SYMPTOMS RETURNED. THE LOSS OF THERAPEUTIC EFFECT OCCURRED ON (B)(6) 2013. IT WAS ADDED THAT PATIENT WAS GETTING SIDE EFFECTS WHEN TRYING TO GET SYMPTOM RELIEF AND THE PAIN WAS ON RIGHT SIDE, SHOULDER, AND ARM AND WAS AFFECTING LEFT BRAIN. IT WAS STATED THAT THE IMPEDANCE TEST WAS PERFORMED WITH ALL ELECTRODES COMBINATIONS AND WAS HIGH WITH THE FOLLOWING READING GREATER 10000 OHMS. IT WAS ADDED THAT THE HEALTHCARE PROVIDER (HCP) WAS UNABLE TO PROGRAM PAST 2.2 MILLIAMPS, AT TWO NEGATIVE, CASE POSITIVE, 60 PULSE WIDTH AND AT 200 RATE AND WAS GETTING A WARNING .IT WAS INDICATED THAT IN CONSTANT CURRENT MODE (HCP) "UNABLE TO PROGRAM PAST CURRENT PARAMETERS". THE PATIENT'S STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT. IT WAS NOTED THAT THE PATIENT WAS BEING SENT FOR AN X-RAY. INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS REPORTED THE ISSUE HAPPENED ON (B)(6) 2013. THE CALLER STATED SHE WOKE UP IN THE MIDDLE OF THE NIGHT AND "SOMETHING WAS SENDING ELECTRICAL CHARGES" TO HER BRAIN. THE CALLER STATED THE HCP BLAMED HER FOR THE REASON IT BROKE. THE CALLER STATED THEY ENDED UP DOING A LEAD REVISION (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316124 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601 00613994934604

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention