BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEAD LOCKING DEVICE EZ/ SPNC LASER SHEATH II

    MDR report key: 1174583 · Received September 17, 2008

    Report

    Report Number
    1721279-2008-00022
    Event Type
    Other
    Date Received
    September 17, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 25, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINICAL HISTORY: THE PT IS A (B) (6), FEMALE WHO UNDERWENT A SINGLE CHAMBER PACER UPGRADE TO A DUAL CHAMBER PACER, WITH A MDT 5032 VDD LEAD IMPLANTED IN 1996. PROCEDURE: LEAD EXTRACTION WAS 1 MINUTE AND 48 SECOND LASER TIME, WITH 4866 PULSES DELIVERED. THE EXTRACTION WAS PERFORMED USING A SPNC 14F SLS II AND 518-062 LLD. APPROX 2 MINS POST-EXTRACTION, THE PT'S BLOOD PRESSURE DROPPED AND AN EMERGENT THORACOTOMY WAS PERFORMED. THE CARDIOTHORACIC SURGEON WAS AT THE PT'S BEDSIDE WITHIN 2 MINS. A SUSPECTED SVC TEAR WAS THE CAUSE OF THE PT'S RAPID INCREASE IN PRESSURE. THE PT HAD AN ARTERIAL LINE IN PLACE DURING THE PROCEDURE AND FLUORO WAS USED THROUGHOUT THE CASE. PT OUTCOME: THE SVC TEAR WAS SUCCESSFULLY REPAIRED, THE PT TRANSFERRED TO THE ICU AND WAS DISCHARGED 5 DAYS LATER. FAILURE ANALYSIS: THE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED BECAUSE NO DEVICES FROM THIS CASE WERE RETURNED TO THE MFR; HOWEVER, THERE WAS NO INDICATION THAT THE EVENT WAS CAUSED BY A MALFUNCTION OF THE SPNC DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD LOCKING DEVICE EZ/ SPNC LASER SHEATH II LLD EZ / 14F SLS II MFA SPECTRANETICS CORP. 518-062/500-012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention SPECTRANETICS CVX-300 LASER