BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5070839 · Received September 11, 2015

    Report

    Report Number
    3004209178-2015-17807
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Report Date
    April 28, 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
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DESKTOP CHARGER ((B)(4)) FOUND THE CABLE ASSEMBLY TO HAVE A DAMAGED TIP.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 3389S-40, LOT# VA0AB21, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387-40, LOT# V000525, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE CONSUMER THAT REPORTED THERE WAS A BROKEN CONNECTOR PIN. THE PATIENT HAD SHAKING, ISSUES WALKING, AND THEY COULD NOT FEED THEMSELVES. THE CHANGE IN THERAPY/SYMPTOMS WAS SUDDEN. THE SYMPTOMS WERE BECAUSE THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS DEPLETED AND HE NEEDED TO RECHARGE. THE LAST SUCCESSFUL RECHARGE WAS SOMETIME A WEEK PRIOR TO REPORT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THE BATTERIES IN THE DEEP BRAIN STIMULATOR (DBS) WERE NOT CHARGING CORRECTLY. THE PATIENT WAS IMPLANTED FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. FURTHER FOLLOW-UP IS BEING CONDUCTED TO DETERMINE WHAT TROUBLESHOOTING OCCURRED AND WHAT ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE ISSUE OF THE DBS BATTERIES NOT CHARGING CORRECTLY AND IF IT WAS ONLY DUE TO THE BROKEN CONNECTOR PIN IN THE DESKTOP CHARGER. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603620 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR