BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE 90-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2153341 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-03199
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY; THEREFORE, THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION 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 DEVICE. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 6. REFERENCE MFR REPORT 1627487-2011-03154, REFERENCE MFR REPORT 1627487-2011-03198, REFERENCE MFR REPORT 1627487-2011-03200, REFERENCE MFR REPORT 1627487-2011-03201. REFERENCE MFR REPORT 1627487-2011-03202.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE 90-CM LENGTH PERCUTANEOUS LEAD TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3149 3208636

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention