BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE 30-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2143082 · Received June 23, 2011

    Report

    Report Number
    1627487-2011-03129
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    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

    THE PATIENT RECEIVED A SCS SYSTEM INCLUDING A PERCUTANEOUS LEAD ON (B)(6) 2010. IT WAS REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2011 BECAUSE OF POSSIBLE FRACTURE. FOLLOW-UP BY SJM REPRESENTATIVE CONFIRMED THE REPLACEMENT LEAD HAD RESOLVED THE PATIENT'S STIMULATION ISSUE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE 30-CM LENGTH PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3163 3094682

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SCS LEAD: MODEL 3166| SCS IPG: MODEL 3788| IMPLANTED:| IMPLANTED: