BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5410908 · Received February 4, 2016

    Report

    Report Number
    3004209178-2016-01548
    Event Type
    Injury
    Date Received
    February 4, 2016
    Report Date
    March 30, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A MANUFACTURING REPRESENTATIVE REPORTED DURING DEVICE FOLLOW UP ON (B)(6) 2016 THE PATIENT HAD INTERMITTENT RETURN OF TREMOR SYMPTOMS. THERE WAS VARIABLE IMPEDANCE NOTED BY THE HEALTHCARE PROFESSIONAL. C/1-17726, 0/1-24195, 1/2-23825, 1/3-18910 WERE OUT OF RANGE IMPEDANCE READINGS FROM (B)(6) 2016. IN (B)(6) CONTACT 1 HAD HIGH IMPEDANCE AND PRIOR TO (B)(6) CONTACT 1 IMPEDANCE WAS OK AND CONTACT 3 WAS OPEN. THE PATIENT WAS REFERRED TO A HEALTHCARE PROFESSIONAL FOR A SURGICAL REVISION ON (B)(6) 2016. PREOPERATIVE ELECTRODE IMPEDANCE WAS DONE ON (B)(6) 2016 AND ALL WERE NORMAL. THE ADAPTOR IN THE POCKET WAS REMOVED IN CASE THIS WAS THE ISSUE AND THE RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED DUE TO THE PATIENT'S DIFFICULTY WITH/INABILITY TO RECHARGE ON THEIR OWN. THE PATIENT HAD NO SUPPORT SYSTEM TO HELP WITH CHARGING SO THE HEALTHCARE PROFESSIONAL MADE THE CHOICE TO REPLACE THE INS WITH A NON-RECHARGEABLE UNIT. ALL ELECTRODE IMPEDANCE WAS NORMAL INTRA-OPERATIVELY AND POST-OPERATIVELY ON (B)(6) 2016. THE ISSUE WAS RESOLVED, PATIENT WAS RECEIVING THERAPY. PATIENT'S MEDICAL HISTORY INCLUDED PARKINSON'S DISEASE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THEY WERE IN THE HOSPITAL AS HE EXPERIENCED A DIZZY SPELL 8 DAYS PRIOR TO REPORT AND HAD EXPERIENCED MORE OF THEM. THEY WERE EXPECTED TO BE THERE UNTIL (B)(6) 2016. THE PATIENT HAD SHOCKING WHILE THEY WERE MOVING AROUND AND USING THEIR MUSCLES. THE LOSS OF THERAPY WAS RELATED TO POSITIONAL MOVEMENT. THERE WAS NO TRAUMA/FALLS/MEDICAL TESTS/EMI RELATED TO THE ISSUE. THEY HAD CHECKED THE DEVICE WITH THE PATIENT PROGRAMMER (PP) AND THE STIMULATION WAS ON. THE LOCATION OF THE SYMPTOMS WAS THE RIGHT NECK/CHEEK. THEY HAD TROUBLE WITH THEIR DEEP BRAIN STIMULATOR (DBS) DEVICE. FURTHER FOLLOW-UP WAS BEING CONDUCTED TO DETERMINE WHAT DIAGNOSTICS/ACTIONS/INTERVENTIONS WERE TAKEN, AND THE CAUSE OF THE DIZZINESS/SHOCKING WAS, AND IF THEIR SYMPTOMS HAD BEEN RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68077 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R