BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESISXP PULSE GENERATOR, 8-CHANNEL

    MDR report key: 2031350 · Received March 23, 2011

    Report

    Report Number
    1627487-2011-00387
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    THE PT WAS IMPLANTED WITH A NON-RECHARGEABLE IPG ON (B)(6) 2004. IT WAS REPORTED THAT HE IS UNABLE TO INITIATE STIMULATION VIA EITHER THE PROGRAMMER OR MAGNET. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT PROGRAMMER WAS SHIPPED TO THE PT. FOLLOW-UP ON THIS ISSUE FOUND THAT THE REPORTED PROBLEM PERSISTS. AS SUCH, SURGICAL INTERVENTION WILL BE UNDERTAKEN TO REPLACE THE PT'S IPG; HOWEVER, A DATE FOR THE PROCEDURE HAS NOT BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESISXP PULSE GENERATOR, 8-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3609 25314A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention