BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4152100 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18499
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 16, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# VA02EUE, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# VA02EUE, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHOCKING/JOLTING SENSATION. THE PATIENT HAD A SHOOTING PAIN DOWN THE RIGHT SIDE OF THE BODY AND UNDER THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAD GONE TO THE EMERGENCY ROOM BUT NOTHING WAS FOUND. THE ACTION REQUIRED AS A RESULT OF THE EVENT WAS OTHER, THEY HAD PLANNED TO MEET TO CHECK IMPEDANCES. IMPEDANCE TESTING WAS DONE. IT WAS UNKNOWN IF THE ISSUE RESOLVED AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT ON (B)(6) 2014 TO CHECK IMPEDANCES AND ALL HAD READ WITHIN NORMAL LIMITS. THE SHOOTING PAIN HAD BEEN A ONETIME EVENT WHILE THE PATIENT WAS SLEEPING AND HAD NOT REOCCURRED. THE PATIENT WAS ALIVE WITH NO INJURY. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO FURTHER TESTING WAS DONE. THE PATIENT WAS DOING WELL AND THERE WAS NO RECURRENCE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632597 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR