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

Model Number 518-062

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/28/2014

Event Type  Injury  

Event Description

This was a lead extraction procedure to remove three cardiac leads for a biv icd system upgrade.The first two leads (sjm 2088tc ra pacing and sjm 2088tc rv pacing, both implanted 14 months) were extracted successfully using an lld-ez and traction only.The third lead (sjm 1388t rv pacing, implanted 183 months) was prepped with an lld-ez and traction was used to pull the lead free, however the tip of the lead got stuck in the subclavian and could not be pulled free through the vasculature.The physician, utilizing his clinical judgment, decided to cut and cap the lead with the lld still inside.The physician completed the device upgrade and the patient experienced no adverse effects related to the procedure.

• 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: 3841677
• MDR Text Key: 4684383
• Report Number: 1721279-2014-00084
• 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: 05/28/2014

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 Expiration Date: 04/01/2015
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP13D01B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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: ST. JUDE MEDICAL 1388T RV PACING (IMPL 183 MONTHS); ST. JUDE MEDICAL 2088TC-46 RA PACING (IMPL 14 MON); SPECTRANETICS LEAD LOCKING DEVICE X2; ST. JUDE MEDICAL 2088TC-52 RV PACING (IMPL 14 MON)
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 79