BEUDAMED
    FDA Adverse Event Other Summary report: N

    LLD #2

    MDR report key: 1198989 · Received September 16, 2008

    Report

    Report Number
    1721279-2008-00029
    Event Type
    Other
    Date Received
    September 16, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    DRB
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE LLDS USED IN THE CASE HAVE BEEN RETAINED BY THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT AND WILL NOT RETURN THEM TO SPECTRANETICS. THE PHYSICIAN WAS REPORTEDLY USING A LOT FORCE WITH THE LLD DEVICES AND IS RELATIVELY NEW AT CARDIAC LEAD REMOVAL PROCEDURES. THE PHYSICIAN DID NOT INDICATE THAT HE THOUGHT THAT THERE WAS ANY MALFUNCTION OF THE SPNC DEVICE.

    Description of Event or Problem · 1

    CLINICAL HISTORY: ADMITTED FOR REMOVAL OF INFECTED LEAD, (B) (6). PROCEDURE: THE LV LEAD WAS PREPPED AND CAME FREE WITH NO COMPLICATIONS. THE A-LEAD WAS PREPPED AND A LLD-2 WAS USED WITH A 14-FRENCH SLS II WITH NO SUCCESS. THE V-LEAD WAS THEN PREPPED AND WAS EXTRACTED WITHOUT HAVING TO LASE. FOCUS WENT BACK TO THE A-LEAD, THE 14-FRENCH SLS II WAS THEN REDEPLOYED OVER THE LLD-2 AND LASER WAS USED FOR 2 MINUTES, 10 SECONDS AND THEN THE OUTER SHEATH WAS INSERTED. AFTER NO SUCCESS GETTING THROUGH A BINDING SITE, THE PHYSICIAN UPSIZED TO A 16-FRENCH SLS II AND USED THE LASER FOR ANOTHER 6 MINUTES, 26 SECONDS. THE PHYSICIAN DETERMINED THAT THE A-LEAD WAS NOT GOING TO BE EXTRACTED SUCCESSFULLY AND THE LASER PROCEDURE WOULD STOP. UPON PULLING OUT THE SLS II, THE PHYSICIAN TRIED TO UNLOCK THE LLD-2, HOWEVER, THE LLD WOULD NOT UNLOCK. THE PHYSICIAN ATTEMPTED FOR SEVERAL MINUTES TO UNLOCK THE LLD WITH NO SUCCESS. THE LLD WAS TO REMAIN IN THE PATIENT AND TO BE CAPPED WITHIN THE A-LEAD. THE A-LEAD WAS IMPLANTED (B) (6) 1999. PATIENT OUTCOME: THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LLD #2 LEAD LOCKING DEVICE DRB SPECTRANETICS CORP. 518-019 070522

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other SPECTRANETICS CVX - 300 LASER