BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPNC LASER SHEATH/LEAD LOCKING DEVICE

    MDR report key: 1631412 · Received March 12, 2010

    Report

    Report Number
    1721279-2010-00012
    Event Type
    Injury
    Date Received
    March 12, 2010
    Date of Event
    January 1, 2010
    Report Date
    March 9, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DAY OF THE CASE IS UNK. ONLY KNOWN INFO IS 01/2010. MFR DATES FOR ALL DEVICES: UNK.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: FRACTURED ICD LEAD. PROCEDURE: THIS WAS A LEFT-SIDED ICD LEAD REMOVAL (IMPLANTED (B) (6) 2006) PROCEDURE CONDUCTED IN THE OR. MD USED A LLD (UNK SIZE) TO ATTACH TO THE DISTAL TIP OF THE LEAD AND LASED WITH A SLS (UNK SIZE). DURING THE EXTRACTION, THE PT'S ARTERIAL PRESSURE DECLINED, AN EMERGENT THORACOTOMY WAS PERFORMED, A SMALL TEAR IN THE SVC WAS REPAIRED SUCCESSFULLY. ANALYSIS: THERE WERE NO DEVICES RETURNED FOR ANALYSIS AND NO LOT HISTORY REVIEW DUE TO VERY LITTLE AVAILABLE DETAILS. NO PRODUCT-RELATED COMPLAINTS ASSOCIATED WITH THIS EVENT REPORTED BY THE PHYSICIAN. PT'S STATUS: THE PT IS REPORTEDLY DOING WELL AND MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC LASER SHEATH/LEAD LOCKING DEVICE SLS / LLD (UNK SIZES) MFA SPECTRANETICS CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention GENERATION 4 EXCIMER LASER