BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIDE-SPACED QUATTRODE, 30-CM LENGTH LEAD

    MDR report key: 2140934 · Received June 21, 2011

    Report

    Report Number
    1627487-2011-03120
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE PT RECEIVED A SCS SYSTEM ALONG WITH SURGICAL LEAD ON (B)(6) 2011. PT CAME IN TO HAVE LEAD TURNED ON. X-RAY ANALYSIS DISCOVERED THAT THE LEAD HAD MIGRATED TOWARDS THE BATTERY POCKET SITE ON THE RIGHT SIDE. A SURGICAL REVISION HAS BEEN SCHEDULED. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIDE-SPACED QUATTRODE, 30-CM LENGTH LEAD SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3163 3301964

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention SCS LEAD: MODEL 3186| SCS IPG: MODEL 3716| IMPLANTED:| SCS ANCHOR: MODEL 1106| IMPLANTED:| IMPLANTED: