BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3213057 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09770
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 25, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN TO THE POST MARKET QUALITY ASSURRENCE LABORATORY THIS LEAD WAS THOROUGHLY ANALYZED. VISUAL INSPECTION CONFIRMED A SEVERED LEAD; 66MM FROM THE TERMINAL PIN, TWO SEGMENTS WERE RETURNED FOR A TOTAL LENGTH OF 910MM. SET SCREW MARKS WERE NOTED ON THE TERMINAL PIN AND THE INSULATION SLEEVE WAS BUNCHED AT 847MM. CUTS WERE OBSERVED IN THE LEAD POLY INSULATION AT 183MM. BLOOD/BODY FLUID WAS CONFIRMED WITHIN THE LEAD LUMEN. EXTENSIVE TESTING WAS PERFORMED TO ASSESS THE LEAD¿S ELECTRICAL INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS DEMONSTRATED CONTINUITY OF THE ELECTRICAL CIRCUITRY. ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED ALLEGATIONS. THE RETURNED LEAD SEGMENTS PASSED ELECTRICAL TESTING.

    Additional Manufacturer Narrative · 1

    FOLLOWING COMPLETION OF LAB ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS SYSTEM WAS HOSPITALIZED FOR A NON-CARDIAC RELATED CONDITION. DURING HOSPITAL ADMISSION, THE PATIENT REPORTEDLY EXHIBITED A VENTRICULAR FIBRILLATION (VF) RATE; HOWEVER, THE DEVICE FAILED TO DELIVER THERAPY. EXTERNAL DEFIBRILLATION AND CPR WERE PERFORMED: SYSTEM UNDERSENSING WAS SUSPECTED. ADDITIONALLY, IT WAS REPORTED THE PHYSICIAN MISPLACED THE PRINTED EPISODES, THUS NO TECHNICAL REVIEW WAS PERFORMED. DURING A SUBSEQUENT DEVICE INTERROGATION, NO EPISODES FROM THIS DATE (OR SURROUNDING DATES) WERE OBSERVED. BOTH THE RIGHT AND LEFT VENTRICULAR LEADS, ALONG WITH THE DEVICE, WERE EXPLANTED. ANOTHER SYSTEM WAS IMPLANTED WITH FAVORABLE MEASUREMENTS OBSERVED. ALL PRODUCTS ARE EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312756 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R