BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS4 PULSE GENERATOR, 4-CHANNEL

    MDR report key: 2092600 · Received May 9, 2011

    Report

    Report Number
    1627487-2011-00626
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE PATIENT ((B)(6)) WAS IMPLANTED WITH A NON RECHARGEABLE IPG ON (B)(6) 2011. IT WAS REPORTED THAT PATIENT'S IPG WAS REPLACED DUE TO COMMUNICATION ISSUES. THE PATIENT ALLEGEDLY NEVER OBSERVED THE LOW BATTERY WARNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS4 PULSE GENERATOR, 4-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3604 3108307

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS LEAD: MODEL UNK| IMPLANTED: