MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD-EZ

Model Number 518-062

Device Problems Device Inoperable (1663); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2014

Event Type  Injury  

Event Description

This was a right-sided lead extraction procedure to remove one non-functional cs lead (mdt 4193 rv pacing, impl 129 months).The lead was prepped with an lld-ez.The physician was planning on extracting the lead with traction only; however after attempting to apply traction the physician determined that the lead had significant scarring and was adhered to two adjacent leads that were not planned for extraction.The physician elected to cut and cap the lead with the lld-ez still inside.The patient was discharged per the operative plan and did not experience any ill-effects from the procedure.The physician stated that the lld performed as intended and no malfunction occurred.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD-EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: jessica hearn bsn, rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4121926
• MDR Text Key: 4925908
• Report Number: 1721279-2014-00155
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Other Device ID Number: PARTIAL UDI: M20551806205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDTRONIC 4193 ATTAIN OTW RV PACING IMPL (B)(6)03
• Patient Outcome(s): Other
• Patient Age: 79 YR