MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND RESONATE; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number G447

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Pericardial Effusion (3271)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

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 with this device sought emergency room assistance due to pain at the implant site.Additional information as later received that during the system implant, a pericardial effusion was noted.No additional medical nor surgical intervention was required and no other adverse effects were reported.To date, this device remains implanted and in service.

• Brand Name: RESONATE
• 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: 7433801
• MDR Text Key: 105587922
• Report Number: 2124215-2018-06797
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/06/2019
• Device Model Number: G447
• Other Device ID Number: RESONATE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2017
• 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
• Treatment: G447; MISMATCH
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR
• Patient Weight: 66