MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND S-ICD SYSTEM

Model Number A219

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/24/2017

Event Type  malfunction  

Manufacturer Narrative

No programming changes were made to the device.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) was in ventricular tachycardia (vt) at a rate of about 180 beats per minute.The device began to double-count approximately 6 seconds into the episode and delivered a shock which then accelerated the rhythm to ventricular fibrillation (vf).Two subsequent shocks were delivered which successfully converted the rhythm.No adverse patient effects were reported.

• Brand Name: S-ICD SYSTEM
• 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: 7665368
• MDR Text Key: 113284252
• Report Number: 2124215-2018-12122
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• 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: Physician
• 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: 04/05/2019
• Device Model Number: A219
• Other Device ID Number: S-ICD EMBLEM MRI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 04/13/2017
• 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: 31 YR