BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3988710 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-14130
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR ((B)(4)) FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708695, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# VA01MBS, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3708695, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V992702, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS HIGH IMPEDANCE OF 40,000 OHMS ON ELECTRODES 10 AND 11. IT WAS NOTED THE DEVICE WAS NOT IMPLANTED AS A RESULT AND IMPEDANCE TESTING WAS PERFORMED. THE EXTENSION WAS REMOVED AND CLEANED AND SCREWED IN ¿AGAIN AND AGAIN.¿ THEY WERE NOT ABLE TO GET PROPER IMPEDANCES SO THEY TRIED A NEW BATTERY AND ¿ALL WENT FINE.¿ THERE WERE NO PATIENT SYMPTOMS AND THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED DURING IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY AFTER NORMAL DEPLETION, IMPEDANCE VALUES OF >40,000 OHMS WERE SEEN. AFTER MULTIPLE ATTEMPTS THEY INSERTED ANOTHER NEW INS AND ALL WAS CLEARED. THE INS WAS FIRST REPLACED DUE TO NORMAL BATTERY DEPLETION BUT THE REPLACEMENT INS WOULD NOT CONNECT PROPERLY. THE PATIENT RECOVERED WITHOUT SEQUELAE AND THERE WAS NO PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465236 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR