BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET PICOTIP

    MDR report key: 3212445 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09626
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 3, 2013
    Report Date
    August 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT ONE MONTH LATER, THIS SURGICALLY ABANDONED LEAD WAS EXTRACTED DUE TO INFECTION. NO RETURN OF THE EXPLANTED LEAD WAS EXPECTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS PART OF A SYSTEM REVISION DUE TO EROSION. ADDITIONALLY, IT WAS REPORTED THIS LEAD EXHIBITED INCREASED PACING THRESHOLD MEASUREMENTS. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS SURGICALLY ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312853 SWEET PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4054

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 6947| 4054| 1821| T165| 0125| 1861| MISMATCH| 4294| 0148| 0155