BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 8011746 · Received October 28, 2018

    Report

    Report Number
    3004209178-2018-24067
    Event Type
    Injury
    Date Received
    October 28, 2018
    Date of Event
    August 15, 2016
    Report Date
    December 21, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: ESTIMATED EVENT DATE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD, UBD: UNKNOWN, UDI#: ASKU. 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

    PRODUCT ID: 3389-40, LOT# 0209038059, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD; PRODUCT ID: 3389-40, LOT# 0209038046, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389-40, LOT# 0209038059, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 3389, LOT# 0209038046, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) OF A CLINICAL STUDY REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. THE PATIENT EXPERIENCED DIZZINESS, AND KEPT TURNING THE DEVICE OFF FOR THIS REASON. DURING UNSCHEDULED CLINIC/OFFICE VISIT, THE INS WAS TURNED ON AND REPROGRAMMED, ALTHOUGH THE DIZZINESS CONTINUED TO BE AN ONGOING ISSUE. DIAGNOSTICS INCLUDED INTERROGATION, THE RESULTS OF WHICH WERE STATED TO BE "NPU". THE PATIENT HAD CEREBRAL HEMORRHAGE DURING PROCEDURE AND SIX MONTHS LATER HAD CONSTANT DIZZINESS. THERE WAS NO CEREBRAL HEMORRHAGE AT THE TIME OF THE REPORT. THE ETIOLOGY WAS DESCRIBED AS RELATED TO IMPLANT PROCEDURE AND NOT RELATED TO DEVICE/THERAPY. INTERVENTIONS INCLUDED REPROGRAMMING AND IMPROVEMENT OF PROGRAMMING. THE EVENT WAS RESOLVED WITHOUT SEQUELAE (B)(6) 2017. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM AN HCP OF A CLINICAL STUDY INDICATED THAT AT THIS TIME THE SUBJECT HAD NO MORE DIZZINESS OR HEADACHES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THAT NO ACTIONS WERE TAKEN FOR CEREBRAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852189 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other