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

Model Number 518-039

Device Problem Cut In Material (2454)

Patient Problems Vascular System (Circulation), Impaired (2572); Device Embedded In Tissue or Plaque (3165)

Event Date 01/24/2014

Event Type  Injury  

Event Description

This was a lead extraction case to remove two leads.The first lead (36 months old, rv pacing, (b)(4)) was prepped with an lld-ez and removed without difficulty.The second lead to be extracted (192 months old, ra pacing, (b)(4)) was prepped with an lld-ez, however, the patient began experiencing some arterial pressure changes and wasn't tolerating the anesthesia well.The physician, using his clinical judgment, decided to cut and cap the lead with the lld-ez inside and abandon the extraction of the second lead because of the patient's safety.The patient stabilized on her own and no intervention was required.The physician decided that he will implant a subq icd lead at a later date.

Manufacturer Narrative

During a review of the file, it was noted that the incorrect product name was included in the report.The name was corrected to lld-e (from lld-ez).

Event Description

This was a lead extraction case to remove two leads.The first lead (36 months old, rv pacing, mdt 5076) was prepped with an lld-e and removed without difficulty.The second lead to be extracted (192 months old, ra pacing, mdt 5068) was prepped with an lld-e, however the patient began experiencing some arterial pressure changes and wasn't tolerating the anesthesia well.The physician, using his clinical judgment, decided to cut and cap the lead with the lld-e inside and abandon the extraction of the second lead because of the patient's safety.The patient stabilized on her own and no intervention was required.The physician decided that he will implant a subq icd lead at a later date.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD-E
• 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: 3602536
• MDR Text Key: 4190249
• Report Number: 1721279-2014-00013
• 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,Followup
• Report Date: 01/24/2014

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: 518-039
• Device Catalogue Number: 518-039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 01/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/19/2014
• 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: SPECTRANETICS LEAD LOCKING DEVICE; TEFLON OUTER SHEATH (MODEL UNKNOWN); MEDTRONIC 5068 CAPSURE FIX RA PACING; MEDTRONIC 5076 CAPSURE FIX RV PACING
• Patient Outcome(s): Other
• Patient Age: 84 YR