BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2062212 · Received March 17, 2011

    Report

    Report Number
    1627487-2011-01269
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 RECORDS FOUND A NONCONFORMANCE RELATED TO THE PRODUCT; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT FUNCTIONALITY. THE PRODUCT WAS REPLACED OR REWORKED AND RELEASED 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 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01270. THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS (FROM SEPARATE LOTS), ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION. DIAGNOSTIC TESTS EXHIBITED INVALID IMPEDANCE READINGS ON ALL LEAD CONTACTS. AN X-RAY SHOWED NO DISCONNECTS OR FRACTURES IN THE LEADS. IT WAS REPORTED THAT THERE APPEARED TO BE A SLIGHT BEND IN ONE OF THE LEADS. IT WAS REPORTED THAT THE PATIENT'S LEADS WILL BE REPLACED OR REVISED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3186 3203885

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention