BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS PULSE GENERATOR, DUAL 4 CHANNEL

    MDR report key: 2080361 · Received April 22, 2011

    Report

    Report Number
    1627487-2011-00534
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    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
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 # 1627487-2011-00535. THE PT RECEIVED AN SCS SYSTEM INCLUDING A NON-RECHARGEABLE IPG AND TWO PERCUTANEOUS LEADS ON (B)(6) 2010. IT WAS REPORTED THAT SHE LOST STIMULATION. DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR SEVERAL LEAD CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN WITH THE INTENT OF REPLACING THE PT'S LEADS; HOWEVER, BEFORE THE PROCEDURE, NO COMMUNICATION COULD BE ESTABLISHED WITH HER IPG. AS SUCH, THE PHYSICIAN DECIDED TO REPLACE THAT DEVICE AS WELL. EFFECTIVE STIMULATION WAS RECAPTURED WITH THE NEW IPG AND LEADS AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS PULSE GENERATOR, DUAL 4 CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3643 2804705

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention