BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD, 60 CM

    MDR report key: 2113709 · Received June 2, 2011

    Report

    Report Number
    1627487-2011-01597
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 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
    FL, 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 1 OF 2. REFERENCE MANUFACTURER NUMBER: 1627487-2011-01598. THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS, ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT FELT INEFFECTIVE STIMULATION COVERAGE. REPROGRAMMING EFFORTS WERE UNSUCCESSFUL AT RESOLVING THE ISSUE. FOLLOW UP ON THE PATIENT FOUND THAT HE LOST STIMULATION. THE PATIENT REPORTED THAT HE WAS UNABLE TO INCREASE STIMULATION PAST PERCEPTION ON ANY OF HIS PROGRAMS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD, 60 CM SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 3170780

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS EXTENSION: MODEL 3342| IMPLANTED:| IMPLANTED:| SCS IPG: MODEL 3788