BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS IMPLANTABLE PULSE GENERATOR

    MDR report key: 1944754 · Received December 15, 2010

    Report

    Report Number
    1627487-2010-02682
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. WE ARE SUBMITTING THIS MDR AS THE RESULT OF A RE-EVALUATION OF OUR MDR REVIEW PROCESS. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2010-04087. THE PT RECEIVED AN SCS SYSTEM, INCLUDING AN IPG AND A SURGICAL LEAD, IN 2006. IT WAS REPORTED THE IPG WAS EXPLANTED AND REPLACED DUE TO NO OUTPUT AND SUSPECTED BATTERY DEPLETION. DURING THE IPG REPLACEMENT PROCEDURE, THE LEAD EXHIBITED HIGH IMPEDANCES ON ALL CONTACTS. THE LEAD WAS ALSO EXPLANTED AND REPLACED. THE EXPLANTED PRODUCTS WERE NOT RETURNED TO THE MFR FOR ANALYSIS. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL -NEUROMODULATION 3608 45990A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention