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

Model Number 4543

Device Problem Failure to Capture (1081)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that this left ventricular (lv) lead showed loss of capture (loc) on the presenting electrogram (egm).The patient also complained of hypotension at home and has seen bradycardia on the presenting.The physician was relayed that the lower rate limit is programmed at 40 bpm, this correlates with heart rate of 47 bpm seen on external telemetry monitor.The patient was seen in the emergency room.The lv output was increased to get consistent capture.Also, the low-rate limit was increased.The pressure immediately improved.The lv lead remains in service at this time.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): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17982885
• MDR Text Key: 326248299
• Report Number: 2124215-2023-58609
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2010
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2008
• 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 Age: 87 YR
• Patient Sex: Male