MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; PACING LEAD

Model Number 4542

Device Problems High impedance (1291); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that, during a routine follow-up, this left ventricular (lv) lead exhibited high out of range pacing impedances.The lead vector was reprogrammed and normal impedances were observed.The physician suspects a conductor fracture.The patient was discharged and will follow-up at another center for a possible lead revision.This lv lead remains in service.No adverse patient effects were reported.

Event Description

It was reported that, during a routine follow-up, this left ventricular (lv) lead exhibited high out of range pacing impedances.The lead vector was reprogrammed and normal impedances were observed.The physician suspects a conductor fracture.The patient was discharged and will follow-up at another center for a possible lead revision.This lv lead remains in service.No adverse patient effects were reported.Additional information was received.At the patient's next follow-up, the pacing impedance measurements were greater than 3,000 ohms in all pacing configurations.The physician decided to have the patient evaluated at another center to determine if a lead revision was needed, or if the device would be reprogrammed to pace only in the right ventricle.No adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.At this time, the lead remains implanted and in service.This report will be updated when additional information is received.

• Brand Name: EASYTRAK 2 IS-1
• Type of Device: PACING LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8581505
• MDR Text Key: 144128286
• Report Number: 2124215-2019-08867
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: 00802526410901
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/19/2005
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 06/20/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1