BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY IPG

    MDR report key: 7152080 · Received December 28, 2017

    Report

    Report Number
    1627487-2017-08708
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Report Date
    December 28, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P140009
    Removal / Correction Number
    1627487/09/12/2017/001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) INACCURATE ELECTIVE REPLACEMENT INDICATOR ADVISORY NOTICE ISSUED BY ABBOTT ON 12SEPTEMBER2017. THE MANUFACTURER HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED ((B)(6)) THAT DIAGNOSTICS INDICATED THE ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGERED EARLIER THAN INTENDED. THE DEVICE HAS THE APPROPRIATE LEVEL OF BATTERY VOLTAGE TO PROVIDE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931228 INFINITY IPG DBS IPG MHY ST. JUDE MEDICAL - NEUROMODULATION 6662 5536559

    Patients

    Seq Age Sex Outcome Treatment
    1