BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1050970 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01904
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 24, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE REPORTED NOISE WAS CONFIRMED IN THE LABORATORY. ANALYSIS FOUND AN ABRASION ON THE IS-1 LEAD OUTER INSUALTION AT 8.1 CM FROM THE CONNECTOR PIN. THE PROXIMAL COIL WAS EXPOSED. THE DAMAGE FOUND IS CONSISTENT WITH FRICTION TO THE ICD CAN. THIS WOULD CAUSE THE REPORTED NOISE PROBLEMS.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A SHOCK WITH SEVERAL VF DETECTIONS DUE TO VENTRICULAR NOISE. NOISE WAS REPEATABLE WHEN WIGGLING THE CHEST. AFTER EXPLANTING THE DEVICE THE PHYSICIAN UNSCREWED ALL THE CONNECTORS OF THE LEAD. THE IS-1 CONNECTOR WAS DIFFICULT TO REMOVE. BLOOD/FLUID WAS OBSERVED ON THE LEAD CONNECTOR. THE PHYSICIAN DOES NOT KNOW WHETHER THIS IS A LEAD OR CONNECTOR ISSUE. THE DEVICE AND LEAD WERE EXPLANTED.

    Description of Event or Problem · 1

    SEVERAL PTS (EXACT NUMBER AND INDIVIDUAL DETAILS NOT PROVIDED TO 3M (B)(4)) EXPERIENCED CRACKS IN THEIR TOOTH STRUCTURE (BOTH LINGUAL AND BUCCAL AREAS) AFTER DENTIST PERFORMED POSTERIOR RESTORATIONS WITH 3M (B)(4) FILETEK SUPREME PLUS FLOWABLE RESTORATIVE, 3M (B)(4) FILETEK SUPREME PLUS UNIVERSAL RESTORATIVE, AND 3M (B)(4) ADPER SINGLE BOND PLUS ADHESIVE. RESTORATIONS WERE EITHER NEW, OR WERE DONE TO REPLACE OLD AMALGAM FILLINGS. SOME PTS HAVE REQUIRED CROWNS OR ROOT CANALS; ALL PTS ARE REPORTED TO BE FINE. DENTIST INDICATED HER TECHNIQUE TO BE AS FOLLOWS: PLACES ABOUT 1 MM OF FILETEK SUPREME PLUS FLOWABLE RESTORATIVE IN BOX AND LIGHT CURES; APPLIES 2 TO 3 COATS OF ADPER SINGLE BOND PLUS ADHESIVE AND LIGHTLY AIR DRIES BETWEEN EACH LAYER AND LIGHT CURES; PLACES FILETEK SUPREME PLUS UNIVERSAL RESTORATIVE GREATER OR LESS THAN 2 MM IN INCREMENTAL DEPTH AND LIGHT CURES FOR 30 SECONDS. DENTIST ALSO INDICATED SHE USES A SLEEVE OVER THE LIGHT GUIDE AND TIP OF THE CURING LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7001/75

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention