BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3132370 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08258
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37602, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMU LATOR; PRODUCT ID 3387S-40, LOT # V023690, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT # V026844, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED HIGH IMPEDANCES ¿THROUGHOUT THE YEAR¿ PRIOR TO REPORT. IT WAS FURTHER REPORTED THAT ¿CONTACT 3 DID NOT WORK¿ AND WAS PROGRAMMED AROUND. IT WAS UNKNOWN AT THE TIME OF REPORT WHICH LEAD CONTACT 3 WAS PART OF. THE PATIENT REPORTED THEY HAD ¿HIT THEIR HEAD, BUT THE IMPEDANCES WERE HIGH EVEN BEFORE HITTING THEIR HEAD.¿ THE PATIENT NOTED AN MRI WAS SCHEDULED ¿TO SEE IF THEY CAN DETECT AN ISSUE WITH THE LEAD." PLEASE SEE MFR. REPORT # 3004209178-2013-08255 FOR INFORMATION ON THE PATIENT'S OTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236752 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1