BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4232754 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21084
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-28, LOT# V193397, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALY. THE INS BATTERY WAS NOT IN NEW CONDITION. SINCE THE ACTUAL IMPEDANCE MEASUREMENTS WERE NOT RECEIVED, THE LONGEVITY WAS CALCULATED WITH ASSUMED 1000O IMPEDANCE FOR RIGHT STN, AND 750O IMPEDANCE FOR THE LEFT STN USED IN UNIPOLAR MODE. THE INS PASSED ALL FUNCTIONAL TESTING. THE ERI BIT WAS SET WHEN THE INS WAS RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. IT WAS NOTICED ONE WEEK PRIOR TO REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED 6 DAYS LATER THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AND THE BATTERY DEPLETION WAS NORMAL. A PLANNED EXPLANT WAS GOING TO OCCUR ON (B)(6) 2014. THE PATIENT¿S DEVICE SETTING WAS IN CONTINUOUS MODE AND THE PATIENT WAS DOING THE ¿SAME AS USUAL.¿ THE PATIENT HAD RECEIVED THE MESSAGE AT HOME. IT WAS FURTHER REPORTED THERE WAS POSSIBLE EARLY DEPLETION OF THE IMPLANTABLE NEUROSTIMULATOR (INS). THERE WAS SUDDEN AND EARLY DEPLETION. THERE WAS NO PATIENT DEATH OR INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713839 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention