BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 2133435 · Received June 15, 2011

    Report

    Report Number
    1627487-2011-00814
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 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

    EVAL: RESULTS: THE LEAD WAS RETURNED OVERSTRESSED WITH WIRES EXPOSED AND INCOMPLETE. AS SUCH, NO FUNCTIONAL TESTING COULD BE PERFORMED. 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

    THE PT RECEIVED AN SCS SYSTEM INCLUDING A PERCUTANEOUS LEAD A (B)(6) 2011. IT WAS REPORTED THAT SHE WAS EXPERIENCING INTERMITTENT STIMULATION AND THAT ONE OF HER LEADS EXHIBITED INVALID IMPEDANCE MEASUREMENTS ON ALL CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN TO ADDRESS THIS MATTER. THE IMPACTED LEAD WAS REPLACED AND EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD WIDE SPACED, 60 CM SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 3263348

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3788| IMPLANTED:| SCS LEAD: MODEL 3341| SCS LEAD: MODEL 3156| IMPLANTED:| IMPLANTED:| SCS LEAD: MODEL 3183| IMPLANTED:| SCS LEAD EXTENSION: MODEL 3386