BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS IMPLANTABLE PULSE GENERATOR

    MDR report key: 1910856 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03626
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROSTIMULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: ANALYSIS OF THE LEAD IS CURRENTLY IN PROGRESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. 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)) RECEIVED AN SCS SYSTEM, INCLUDING AN UNKNOWN LEAD, ON (B)(6) 2009. IT WAS REPORTED THE LEAD WAS EXPLANTED AND REPLACED AS IT WAS "BROKEN." THE EXPLANTED LEAD WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. AS THE LEAD MODEL AND LOT NUMBERS WERE NOT PROVIDED, NO MANUFACTURING OR EXPIRATION DATE COULD BE DETERMINED. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROSTIMULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention