BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINCH ANCHOR

    MDR report key: 2091612 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-01435
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    K081208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT FUNCTIONALITY OR PRODUCT INTEGRITY. THE DEVICE WAS, THEREFORE, APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. 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 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 4 OF 4. REFERENCE MANUFACTURER REPORTS: 1627487-2011-01432, 1627487-2011-01433 AND 1627487-2011-01434. THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, SURGICAL LEAD, AND TWO ANCHORS, ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD INSERTION SITE. THE PHYSICIAN EXPLANTED THE PATIENT'S SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT A CULTURE WAS TAKEN, BUT THE RESULTS ARE UNDETERMINED. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY; THEREFORE, THEY WILL NOT BE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINCH ANCHOR SPINAL CORD STIMULATION LEAD ANCHOR GZB ST. JUDE MEDICAL - NEUROMODULATION DIVISION 1194 2898820

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R