BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II STEROX

    MDR report key: 2071115 · Received April 27, 2011

    Report

    Report Number
    2124215-2011-07440
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 24, 2011
    Report Date
    December 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    DURING A FURTHER FOLLOW-UP VISIT, INTERROGATION REVEALED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. A LEAD FRACTURE WAS SUSPECTED. IN ADDITION, AN X-RAY REVEALED A BEND IN THE LEAD AS THE PATIENT WITH THIS LEAD HAS AN INTRINSIC HEART RATE, NO ADVERSE PATIENT SYMPTOMS WERE NOTED. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED.

    Description of Event or Problem · 1

    DURING A FURTHER FOLLOW-UP VISIT, INTERROGATION REVEALED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. A LEAD FRACTURE WAS SUSPECTED. IN ADDITION, AN X-RAY REVEALED A BEND IN THE LEAD AS THE PATIENT WITH THIS LEAD HAS AN INTRINSIC HEART RATE, NO ADVERSE PATIENT SYMPTOMS WERE NOTED. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD WITH NON-BOSTON SCIENTIFIC DEVICE DISPLAYED INCREASED IMPEDANCE AND THRESHOLD MEASUREMENTS. IN ADDITION, A REVIEW OF THE DEVICE MEMORY REVEALED OVERSENSING. NO LOSS OF THERAPY WAS OBSERVED. AN X-RAY REVEALED NO ABNORMALITIES. A REVISION PROCEDURE WAS PERFORMED. THE DEVICE WAS REMOVED FROM THE PATIENT THIS LEAD COULD BE REMOVED WITHOUT LOOSENING THE SETSCREW. IT WAS THOUGHT THIS LEAD HAD NOT BEEN COMPLETED INSERTED INTO THE DEVICE HEADER AND WAS THE REASON FOR THE REPORTED CLINICAL OBSERVATIONS. AS MEASUREMENTS OBTAINED WITH THE PACING SYSTEM ANALYZER WERE ACCEPTABLE, A DECISION WAS MADE TO REPLACE THE DEVICE. THE DEVICE WAS REPLACED AND THIS LEAD WAS CONNECTED TO THE REPLACEMENT DEVICE. NORMAL MEASUREMENTS WERE OBTAINED. THE PATIENT WITH THIS LEAD HAS AN INTRINSIC HEART RATE AND IS NOT PACEMAKER DEPENDENT. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE II STEROX IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4371

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 291-03| 483-01| MISMATCH| 4371| 4369| 253-19