BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLAIM¿ IPG

    MDR report key: 6919428 · Received October 6, 2017

    Report

    Report Number
    1627487-2017-05844
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    September 11, 2017
    Report Date
    October 5, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487/09/12/2017/001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICES: THE THERAPY DATE FOR THE FOLLOWING DEVICE IS UNKNOWN: MODEL: 3186; SCS LEAD. THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) INACCURATE ELECTIVE REPLACEMENT INDICATOR ADVISORY NOTICE ISSUED BY ABBOTT ON 12 SEPTEMBER 2017. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED ((B)(6)) THE REPLACE GENERATOR SOON MESSAGE WAS DISPLAYED ON THE PATIENT CONTROLLER INDICATING THE GENERATOR WAS APPROACHING ITS END OF SERVICE. DIAGNOSTICS INDICATED THE MESSAGE WAS PREMATURELY DISPLAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702798 PROCLAIM¿ IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3665 5816058

    Patients

    Seq Age Sex Outcome Treatment
    1