BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2041596 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01333
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGICALLY REMOVED PORTION OF THE LEAD WAS SIGNIFICANTLY STRETCHED AND DAMAGED AND IS NOT EXPECTED FOR RETURN TO BOSTON SCIENTIFIC. THE REST OF THE LEAD WAS SURGICALLY ABANDONED. A NEW BOSTON SCIENTIFIC LEAD OF A DIFFERENT MODEL WAS SUCCESSFULLY IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, INVESTIGATION IS CONSIDERED COMPLETE. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT ATRIAL (RA) LEAD WAS PARTIALLY REMOVED FROM SERVICE AS A RESULT OF FRACTURE. LOSS OF CAPTURE, LACK OF SENSING AND PACE IMPEDANCE OF LESS THAN 200 OHMS WERE ALL EVIDENT. THE PHYSICIAN ALSO NOTICED UPON VISUAL INSPECTION, THAT THE LEAD HAD A FEW TINY PIN HOLES IN THE INSULATION APPROXIMATELY 15 CENTIMETERS FROM THE TERMINAL PIN. THERE WERE NO ADVERSE PATIENT EFFECTS BEYOND THE EARLY SURGICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4063

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 4469| 0148| 1861| 4063| E110