MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0273

Device Problem Pocket Stimulation (1463)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, an evaluation of this lead was performed.Complete lead was returned intact and not severed.Noted electro-cautery damage in the outer insulation likely explant damage.Visual inspection revealed no abnormalities other than induced damage from normal use.Laboratory analysis was to confirm the reported allegation.

Event Description

It was reported that this right ventricular (rv) lead caused the patient to experience muscle stimulation.This lead was explanted.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 13462313
• MDR Text Key: 285168943
• Report Number: 2124215-2021-41078
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526601811
• UDI-Public: 00802526601811
• 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
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/07/2023
• Device Model Number: 0273
• Device Catalogue Number: 0273
• Device Lot Number: 113114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male