BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD 3/4MM, 30 CM

    MDR report key: 2092667 · Received May 10, 2011

    Report

    Report Number
    1627487-2011-00630
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    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 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 2 OF 3. REFERENCE MFR REPORT #S: 1627487-2011-00629 AND 1627487-2011-00631. THE PT RECEIVED AN SCS SYSTEM INCLUDING TWO PERCUTANEOUS LEADS (FROM DIFFERENT LOTS) AND A LEAD EXTENSION ON (B)(6) 2007. THE PT RECEIVED A NEW EXTENSION ON (B)(6) 2008. IT WAS REPORTED THAT THE PT WAS NO LONGER RECEIVING THERAPY COVERAGE IN HER BACK. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE READINGS FOR SEVERAL LEAD CONTACTS. EFFORTS TO RECAPTURE EFFECTIVE THERAPY VIA REPROGRAMMING PROVED UNSUCCESSFUL. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO REPLACE THE PT'S LEADS AND LEAD EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD 3/4MM, 30 CM SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3143 55537

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCS LEAD: MODEL 3186| IMPLANT DATE:| SCS IPG: MODEL 3716| IMPLANT DATE: