BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY¿ IPG

    MDR report key: 6915964 · Received October 5, 2017

    Report

    Report Number
    1627487-2017-05789
    Event Type
    Injury
    Date Received
    October 5, 2017
    Report Date
    October 10, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P140009
    Removal / Correction Number
    1627487/09/12/2017/001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE THERAPY DATE(S) FOR THE FOLLOWING DEVICE(S) IS UNKNOWN: MODEL: 6171(X2); DBS LEAD, MODEL: 6372(X2); DBS EXTENSION. SJM 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S ((B)(6)) IPG EXHIBITED A LOW LONGEVITY ESTIMATE. PER THE COMPANY REPRESENTATIVE, THE DEVICE HAD NOT REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT AND REPLACE THE IPG. STIMULATION WAS RESTORED POST-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695746 INFINITY¿ IPG DBS IPG MHY ST. JUDE MEDICAL - NEUROMODULATION 6660 5209377

    Patients

    Seq Age Sex Outcome Treatment
    1 Other