MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number 4543

Device Problems Pocket Stimulation (1463); Difficult to Remove (1528)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 03/27/2012

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this left ventricular (lv) lead caused the patient to experience diaphragmatic stimulation and discomfort.Moreover, the patient was feeling shocks on the left side of the body since implant.The patient will have another clinic visit for reprogramming.Boston scientific technical services (ts) referred the patient to physician for further evaluation.Additional information obtained from the field which indicated that the physician tried to replace this lead at the time of pacemaker replacement but was not successful at that time.Thus, boston scientific technical services (ts) again discussed options.As of this time, the lead remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided future, a supplemental report will be issued.Correction to field b2: date of event and h10: additional mfr narrative.

Event Description

It was reported that this left ventricular (lv) lead caused the patient to experience diaphragmatic stimulation and discomfort.Moreover, the patient was feeling shocks on the left side of the body since implant.The patient will have another clinic visit for reprogramming.Boston scientific technical services (ts) referred the patient to physician for further evaluation.Additional information obtained from the field which indicated that the physician tried to replace this lead at the time of pacemaker replacement but was not successful at that time.Thus, boston scientific technical services (ts) again discussed options.As of this time, the lead remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that this left ventricular (lv) lead caused the patient to experience diaphragmatic stimulation and discomfort.Moreover, the patient was feeling shocks on the left side of the body since implant.The patient will have another clinic visit for reprogramming.Boston scientific technical services (ts) referred the patient to physician for further evaluation.Additional information obtained from the field which indicated that the physician tried to replace this lead at the time of pacemaker replacement but was not successful at that time.Thus, boston scientific technical services (ts) again discussed options.As of this time, the lead remains in service.No additional adverse patient effects were reported.Subsequently, this lead was surgically abandoned.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided future, a supplemental report will be issued.Correction to field b2: date of event and h10: additional mfr narrative.

• Brand Name: EASYTRAK 2 IS-1
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• 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: 12184644
• MDR Text Key: 262069092
• Report Number: 2124215-2021-19313
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/17/2013
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 169934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 11/14/2022; 04/19/2023
• Supplement Dates FDA Received: 11/25/2022; 05/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2011
• 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: 80 YR
• Patient Sex: Female