BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE 90-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2153326 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-03198
    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
    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

    EVAL 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 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 6. REFERENCE MFR REPORT 1627487-2011-03154, 1627487-2011-03199, 1627487-2011-03200, 1627487-2011-03201, 1627487-2011-03202. THE PT RECEIVED A SCS SYSTEM ON (B)(6) 2011 FOR MIGRAINES. IT WAS REPORTED THE PT SUDDENLY LOST STIMULATION AND THE PT'S EXTENSION THAT CONNECTED TO THE OCCIPITAL LEADS WAS BROKEN. THE DOCTOR ALSO OBSERVED THAT THE PT'S IPG POCKET WAS INFECTED. HE THEN EXPLANTED THE ENTIRE SYSTEM. THE PT WAS TREATED WITH ANTIBIOTIC AND LATER REPORTED THE INFECTION HAD RESOLVED. THE PT WAS REIMPLANTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE 90-CM LENGTH PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3149 3308418

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention