BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATCH

    MDR report key: 1953980 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24140
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    June 26, 2008
    Report Date
    December 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE DEVICE WAS EXPLANTED IN (B)(6) 2008, THE DEVICE AND SEVERED LEADS WERE RETURNED TO BOSTON SCIENTIFIC IN (B)(6) 2010. A REVIEW OF MEDICAL RECORDS INDICATED THAT THE PATIENT EXPIRED IN (B)(6) 2008. NO CAUSE OF DEATH WAS REPORTED. NO NEW BOSTON SCIENTIFIC SYSTEM HAD BEEN IMPLANTED, AND IT WAS NOT KNOWN IF THE PATIENT HAD RECEIVED A COMPETITIVE SYSTEM. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THE DEVICE WAS EXPLANTED AND ALL FOUR LEADS, INCLUDING THE EPICARDIAL RATE/SENSE LEADS, WERE CUT AND ABANDONED. THE SURGEON DID NOT USE LEAD CAPS BUT MAY HAVE USED SUTURE TIES. THERE WAS NO INJURY TO THE PATIENT; IT WAS NOT KNOWN WHEN OR IF A NEW SYSTEM WAS TO BE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATCH IMPLANTABLE LEAD NHW CPI - DEL CARIBE 0068

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 0067| 1852| 4440| E030| 0068| 4046