BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3960852 · Received July 28, 2014

    Report

    Report Number
    9614453-2014-01555
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 7, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(4) 2014, THE IMPLANTABLE NEUROSTIMULATOR (INS) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE REPORTER STATED THAT PREMATURE BATTERY LIFE WAS SUSPECTED. IT WAS NOTED THERE WAS AN ERI NOTIFICATION FOR SIX DAYS. IT WAS FURTHER NOTED THAT IMPEDANCE TESTING AND REPROGRAMMING WAS DONE. THE REPORTER STATED THE INS WAS REPLACED ON (B)(6) 2014. IT WAS NOTED THE PATIENT WAS PROGRAMMED WITH THE FOLLOWING SETTINGS ¿1-, 9-/ P 330 AND R 150.¿ IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS FURTHER NOTED THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE INS WAS EXPLANTED ON (B)(6) 2014. THE REPORTER STATED THAT NO LONGEVITY CALCULATION WAS DONE. IT WAS FURTHER NOTED THAT SOME ELECTRODES ON THE RIGHT HEMISPHERE WERE OUT OF RANGE. IT WAS NOTED THAT C AND 11 HAD AN IMPEDANCE OF 2456 OHMS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437494 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention