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

Model Number 4543

Device Problems No Apparent Adverse Event (3189); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2022

Event Type  Injury  

Event Description

It was reported that this crt-d emitted tones due to low oor pli on the right ventricular (rv) lead, then several years later the shock lead impedance went from normal values to high, out of range.The pacing impedance also increased but still showed within range pacing impedances.Also, the pacing threshold rose up.With a bit of movement, there was some subtle noise on rv lead pace/sense channel, but not on shock channel.A conductor issue of some kind was considered.The lead is likely to be revised soon.Other reprogramming options were considered, and it was mentioned that some reprogramming changes had already been completed.A commanded shock was not considered as the patient is in end stage renal failure.No falls or other medical changes to account for change either.At this time the rv lead and the left ventricular (lv) lead were explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this crt-d emitted tones due to low oor pli on the right ventricular (rv) lead, then several years later the shock lead impedance went from normal values to high, out of range.The pacing impedance also increased but still showed within range pacing impedances.Also, the pacing threshold rose up.With a bit of movement, there was some subtle noise on rv lead pace/sense channel, but not on shock channel.A conductor issue of some kind was considered.The lead is likely to be revised soon.Other reprogramming options were considered, and it was mentioned that some reprogramming changes had already been completed.A commanded shock was not considered as the patient is in end stage renal failure.According to the field representative, the patient fell of a scooter and fractured his rv lead.The left ventricular (lv) lead already had chronically high thresholds.The patient had access issues due to dialysis so could not have the device/leads revised and/or implanted from the right side.Extraction was ordered and was a difficult case likely further compromising any chance of access on the left side.The entire system with the rv and lv leads was explanted and replaced with a subcutaneous implantable cardioverter defibrillator.Nothing is being returned as all the leads were shredded during extraction and fished out using snares.Device was sent to pathology.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16076654
• MDR Text Key: 306405471
• Report Number: 2124215-2022-55544
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/20/2012
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 157886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2010
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male