BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2992528 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03435
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 14, 2013
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-95, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION: PRODUCT ID 37085-95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387S-40, LOT# V606250, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V754192, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NOTICED A CALL YOUR DOCTOR ICON AND RECEIVED AN ESTIMATED REPLACEMENT INDICATOR MESSAGE ON THEIR PATIENT PROGRAMMER. IT WAS ALSO REPORTED THE PATIENT'S DEVICE WAS SET AT 3.3 AND 4.0 VOLTS AND THE PATIENT WAS TOLD THE DEVICE WOULD LAST THREE TO FIVE YEARS BUT THE PATIENT ONLY HAD THE DEVICE IMPLANTED FOR LESS THAN TWO YEARS. IT WAS REPORTED THE PATIENT WAS SCHEDULED TO MEET WITH THEIR HEALTHCARE PROVIDER ON (B)(6) 2013 TO CHECK THE PATIENT'S BATTERY STATUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S REPLACEMENT DEVICES WERE RETURNED TO HER PRIOR SETTINGS. THE REPORTER STATED THAT THE PATIENT'S CONDITION WAS UNKNOWN AFTER SHE LEFT THE HOSPITAL.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96674 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention