MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 0295

Device Problems Pocket Stimulation (1463); Defective Device (2588)

Patient Problems Device Overstimulation of Tissue (1991); Perforation (2001)

Event Date 03/17/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that the patient with this right ventricular (rv) lead experienced diaphragmatic stimulation.In addition, the physician also suspected possible lead perforation.The lead was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the perforation as reported patient code cannot be confirmed by product analysis but was assigned cause which is known inherent risk of device, based on the field report.The muscle or pocket stimulation allegations were not confirmed by product analysis but were assigned cause which is known inherent risk of device, based on the field report.During analysis several abrasions were noted on the lead in an area on the lead which should have been located within the heart while implanted.The abrasions are consistent with some type of crushing damage.This damage will be addressed with new lines of code.

Event Description

It was reported that the patient with this right ventricular (rv) lead experienced diaphragmatic stimulation.In addition, the physician also suspected possible lead perforation.The lead was explanted.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE G
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 14107749
• MDR Text Key: 289249492
• Report Number: 2124215-2022-10035
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526531262
• UDI-Public: 00802526531262
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2018
• Device Model Number: 0295
• Device Catalogue Number: 0295
• Device Lot Number: 390034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2016
• 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): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male