BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2151409 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-09700
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    July 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS COULD NOT CONFIRM THE CLINICAL OBSERVATIONS OF A FRACTURE. UPON RECEIPT AT OUR (B)(4) LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED THE LEAD SEVERED 81 MILLIMETER FROM THE TERMINAL PIN WITH 2 SEGMENTS RETURNED, TOTALLING IN LENGTH TO 730 MM. THE LEAD WAS NOTED AS SEVERELY TWISTED AND STRETCHED. CUTS AND BUNCHING WERE ALSO FOUND IN THE INSULATION. THE LEAD DID NOT PASS THE GUIDEWIRE TEST DUE TO THE PRESENCE OF BLOOD/BODY FLUID. EXTRACTING STYLET WAS RETURNED STUCK IN THE SECOND SEGMENT OF THE LEAD. THIS WAS RETURNED SEVERED WITH THE EXTRACTION STYLET STUCK IN THE LEAD. THE LEAD IS SEVERELY TWISTED AND STRETCHED. ALL OF THE DAMAGE APPEARS TO BE FROM EXPLANT.

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS COULD NOT CONFIRM THE CLINICAL OBSERVATIONS OF A FRACTURE. UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED THE LEAD SEVERED 81 MILLIMETER FROM THE TERMINAL PIN WITH 2 SEGMENTS RETURNED, TOTALLING IN LENGTH TO 730 MM. THE LEAD WAS NOTED AS SEVERLY TWISTED AND STRETCHED. CUTS AND BUNCHING WERE ALSO FOUND IN THE INSULATION. THE LEAD DID NOT PASS THE GUIDEWIRE TEST DUE TO THE PRESENCE OF BLOOD/BODY FLUID. EXTRACTING STYLET WAS RETURNED STUCK IN THE SECOND SEGMENT OF THE LEAD. THIS WAS RETURNED SEVERED WITH THE EXTRACTION STYLET STUCK IN THE LEAD. THE LEAD IS SEVERLY TWISTED AND STRETCHED. ALL OF THE DAMAGE APPEARS TO BE FROM EXPLANT.

    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 RIGHT VENTRICULAR (RV) LEAD HAD SUSTAINED SUBCLAVIAN DAMAGE RESULTING IN A FRACTURE TO THE LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4035

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)