BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST OPTIM

    MDR report key: 2181912 · Received July 21, 2011

    Report

    Report Number
    2181912
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOTES FROM THE CONSULTATION: AN INITIAL ICD WAS IMPLANTED 6 YEARS AGO. AT THE TIME OF HIS GENERATOR CHANGE 2 YEARS AGO, HE WAS FOUND TO HAVE FRACTURE OF BOTH LEADS DEEP TO THE DEVICE ITSELF WITHIN THE POCKET. THERE WAS NO DISCERNIBLE CAUSE. THE LEADS WERE REMOVED AND REPLACED AS WELL AS THE DEVICE AT THAT TIME. WITHIN THE PAST SEVERAL MONTHS, HE RECEIVED AN INAPPROPRIATE ICD SHOCK AND HE HAS HAD INTERMITTENT NOISE ON BOTH THE ATRIAL AND VENTRICULAR LEADS. IT IS NOW THOUGHT THAT HE SHOULD UNDERGO LEAD EXTRACTION AND REPLACEMENT WITH A NEW ST. JUDE 7120Q/58 ELECTRODE FOR THE HIGH VOLTAGE LEAD. THIS WOULD NECESSITATE THE REPLACEMENT OF HIS ICD GENERATOR.NOTES FROM THE DISCHARGE SUMMARY: ... HIS DEVICE WAS ALSO IMPINGING ON HIS LEFT DELTO-PECTORAL GROOVE/SHOULDER CREASE, AND IT IS THOUGHT THAT THIS MIGHT HAVE CONTRIBUTED TO THE LEAD FRACTURE. HOSPITAL COURSE: THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE HE WAS FOUND TO HAVE LEAD FRACTURES, ONE AT THE SITE OF FIXATION OF THE RV LEAD TO THE CHEST WALL DEEP TO THE PROTECTIVE "SUTURE SLEEVE" IN THE ATRIAL LEAD AND AT AN UNDETERMINED SITE, ALTHOUGH FLUID WAS PRESENT WITHIN THE INSULATION OF THE LEAD. THESE LEADS WERE REMOVED AND LEAD REPLACED. THE POCKET WAS MODIFIED TO PLACE THE DEVICE IN A MORE CAUDAL AND MEDIAL LOCATION AND AN ADVANCED LEAD SYSTEM WERE EMPLOYED FOR THE RV DUAL COIL ELECTRODE. POSTOPERATIVELY, THE PATIENT HAD NO DIFFICULTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM LEAD, DEFIBRILLATION LWS ST. JUDE MEDICAL 7020 *
    2 TENDRIL ST OPTIM LEAD, PACEMAKER DTB ST. JUDE MEDICAL 1888TC *
    3 CURRENT DR RF DEFIBRILLATOR, IMPLANTABLE LWS ST. JUDE MEDICAL 2207-36 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR