BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4438649 · Received January 21, 2015

    Report

    Report Number
    3004209178-2015-01036
    Event Type
    Malfunction
    Date Received
    January 21, 2015
    Report Date
    December 30, 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

    CONCOMITANT: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 3387S-40, LOT# V298925, IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3387S-40, LOT# V298925, IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE LOW OUT OF RANGE IMPEDANCE READINGS. THEY WERE AT THE POST-OPERATION AFTER A PRIMARY CELL DEVICE WAS REPLACED AND THEY HAD NOTED 9/11 PAIR HAD IMPEDANCE OF 39 OHMS. THE SHORT WAS FIRST NOTICED ON THE DATE OF THIS REPORT. IMPEDANCES WERE C/11-605, C/9-610, C/8-1285, C/10-867, 8/9-1323, 8/10-1683, 8/11-1315, 9/10-785, 9/11-39, 10/11-789. THEY WERE UNSURE OF THERAPY STATUS BUT THE PATIENT HAD BEEN PROGRAMMED TO 9-10 PRIOR TO THE REPLACEMENT ON THE DATE OF THIS REPORT. NO OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPEDANCE ISSUE WAS RESOLVED TO SOME DEGREE. THE PATIENT WAS PROGRAMMED BY THE DOCTOR AND DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. THE CAUSE OF THE IMPEDANCES WAS UNKNOWN. THE REPORTER HAD NOT HEARD FROM THE PATIENT SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50340 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR