BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2821115 · Received October 25, 2012

    Report

    Report Number
    1627487-2012-11570
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 3, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-11569. IT WAS REPORTED, THE PATIENT HAD STIMULATION IN HER RIBS. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND ATTEMPTED REPROGRAMMING, BUT THE ISSUE COULD NOT BE RESOLVED. THE PHYSICIAN HAD X-RAYS TAKEN WHICH REVEALED THE LEADS HAD MIGRATED. IT WAS REPORTED THE PHYSICIAN PLANNED SURGICAL INTERVENTION TO REPLACE THE LEADS AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 3593604

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SCS ANCHOR, MODEL 1192 (2)| SCS IPG, MODEL 3788| IMPLANT DATE:| IMPLANT DATE: