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

Model Number 4543

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631); Material Integrity Problem (2978); High Capture Threshold (3266)

Patient Problem Heart Failure (2206)

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

As no additional information regarding this event is expected, our investigation is complete.This record will be updated if additional information becomes available.

Event Description

It was reported that pacing impedances on this left ventricular (lv) lead were increasing and had reached greater than 2000 ohms.Additionally, thresholds were high.Reportedly, these issues resulted in compromised biventricular pacing and the patient reported increased heart failure symptoms.The clinician reprogrammed the patient's implanted device to use an alternate lv pacing vector, which reportedly resolved the issue.No additional adverse patient effects were reported.This lv lead and the patient's implanted device remain in service.

Manufacturer Narrative

As no additional information regarding this event is expected, our investigation is complete.This record will be updated if additional information becomes available.

Event Description

This report is being filed as additional information has been received indicating that pacing impedances on this left ventricular (lv) reached greater than 2500 ohms in all available pacing configurations, although the lead was able to capture in one vector.The lv lead was surgically abandoned and replaced.The physician reportedly suspected that the out of range impedances and threshold issues were due to lead damage in the area of the left clavicle.The physician elected to replace the patient's cardiac resynchronization therapy defibrillator (crt-d) during the same procedure.No additional adverse patient effects were reported.

• Brand Name: EASYTRAK 2 IS-1
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8557854
• MDR Text Key: 143397459
• Report Number: 2124215-2019-07815
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/19/2016
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 187984
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR