BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPATH MEDICAL BIPOLAR LEAD

    MDR report key: 2133588 · Received June 16, 2011

    Report

    Report Number
    2183787-2011-00047
    Event Type
    Injury
    Date Received
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: REVIEW OF MANUFACTURING RECORDS WAS PERFORMED. RESULTS: REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. CONCLUSIONS: DEVICE IS PART OF SEVERAL IMPLANTED COMPONENTS THAT COMPRISE A PACING SYSTEM. ANOTHER DEVICE, THE ADAPTER (EXTENDER) CAUSED THE FAILURE. THIS LEAD REMAINS IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC REC'D INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING IMPEDENCE AND NOISE. IT IS BELIEVED THAT THE EXTENDER (ADAPTER) USED ON THIS LEAD HAD FRACTURED. THE EXTENDER (ADAPTER) WAS EXPLANTED AND SUCCESSFULLY REPLACED. THIS LEAD REMAINS IMPLANTED. UPDATED INFORMATION REC'D (B)(6) 2011: THE DEVICE WAS EXPLANTED AS A PRECAUTIONARY MEASURE AND THIS LEAD WAS RE-USED ON A NEWLY IMPLANTED DEVICE. TO DATE, THERE HAVE BEEN NO ADVERSE PT EFFECTS REPORTED. UPDATED INFORMATION REC'D (B)(6) 2011: THE EXTENDER WAS EXPLANTED AND SUCCESSFULLY REPLACED. THIS LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPATH MEDICAL BIPOLAR LEAD BIPOLAR LEAD, 35 CM DTB GREATBATCH MEDICAL 511211 62610

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention