BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS 8-CHANNEL IPG

    MDR report key: 1940599 · Received December 21, 2010

    Report

    Report Number
    1627487-2010-03877
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 RECEIVED HER SCS SYSTEM ON (B)(6) 2010, CONSISTING OF AN IPG AND PERCUTANEOUS LEAD. IT WAS REPORTED THAT THE PATIENT RECENTLY LOST STIMULATION. DIAGNOSTIC TESTS TAKEN SHORTLY THEREAFTER REVEALED INVALID IMPEDANCE READINGS FOR ALL LEAD CONTACTS. AS SUCH, SURGICAL INTERVENTION WAS SCHEDULED FOR (B)(6) 2010 TO ADDRESS THE LEAD ISSUE. HOWEVER, IT WAS LATER DISCOVERED THAT THE PATIENT COULD NOT COMMUNICATE WITH HER IPG USING THE PROGRAMMER. AN X-RAY OF THE PATIENT'S SCS SYSTEM WAS TAKEN IN THE OPERATING ROOM, BUT NO VISIBLE ANOMALIES WERE DETECTED. AT THAT TIME, THE PATIENT'S LEAD WAS ALSO TESTED AND IMPEDANCE READINGS WERE FOUND TO BE WITHIN SPECIFICATIONS. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO ESTABLISH COMMUNICATION WITH THE IPG, A DECISION WAS MADE TO REPLACE THE DEVICE. WHEN USING THE NEW IPG IN CONJUNCTION WITH THE PATIENT'S EXISTING LEAD, EFFECTIVE STIMULATION WAS RECAPTURED AND IMPEDANCE READINGS WERE WITHIN SPECIFICATIONS. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS 8-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3608 2852577

    Patients

    Seq Age Sex Outcome Treatment
    1