MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND S-ICD SYSTEM; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number A209

Device Problems Failure to Convert Rhythm (1540); Defibrillation/Stimulation Problem (1573); Under-Sensing (1661); Device Operates Differently Than Expected (2913)

Patient Problems Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

This device remains in service.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) had a ventricular tachycardia (vt) event.An appropriate shock was delivered which accelerated the rhythm to ventricular fibrillation (vf).Some undersensing was noted however therapy was successfully delivered and the vf was converted.Boston scientific technical services (ts) discussed sensing and shock polarity.No adverse patient effects were reported.

• Brand Name: S-ICD SYSTEM
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7665409
• MDR Text Key: 113283013
• Report Number: 2124215-2018-12142
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: 00802526544101
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/29/2017
• Device Model Number: A209
• Other Device ID Number: EMBLEM S-ICD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2015
• 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: 41 YR