BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1410956 · Received July 9, 2009

    Report

    Report Number
    2017865-2009-02175
    Event Type
    Injury
    Date Received
    July 9, 2009
    Date of Event
    May 25, 2009
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH PACING LEAD IMPEDANCE WAS OBSERVED. THE LEAD WILL BE EXPLANTED.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER VIA FDA MEDWATCH PROGRAM (B)(4) AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A PT WHO RECEIVED SUPER POLIGRIP DENTURE ADHESIVE CREAM (FORMULATION UNK) FOR DENTURE ADHESION. CO-SUSPECT MEDICATION INCLUDED FIXODENT AND SEA BOND DENTURE ADHESIVE. IN 1999, THE PT STARTED USING SUPER POLIGRIP (DENTAL), FIXODENT (DENTAL) AND SEA BOND (DENTAL) DAILY. AT AN UNK TIME AFTER STARTING SUPER POLIGRIP, FIXODENT AND SEA BOND, THE PT EXPERIENCED NUMBNESS AND TINGLING OF EXTREMITIES. THE PT WAS DIAGNOSED WITH NEUROPATHY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. THE REGULATORY AUTHORITY CONSIDERED THE EVENTS TO BE DISABLING. THE PT WAS TOLD THAT THEY HAD BEEN EXPOSED TO SOME SORT OF TOXIN THAT CAUSED NERVE DAMAGE IN LEGS. SUPER POLIGRIP, FIXODENT AND SEA BOND WERE DISCONTINUED. AT THE TIME OF REPORTING THE EVENTS WERE UNRESOLVED. THE MANUFACTURER REPORT NUMBER FOR THIS CASE IS 9681138-2009-00063. SUPER POLIGRIP IS MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention