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 Pulmonary Embolism (1498); Pain (1994)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

The 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 from a clinical study form that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) experienced pain in the right shoulder/chest area about three weeks post-implant.A pulmonary embolism (pe) was identified and the patient was prescribed medications and released to home.The cause of the pe was unknown, but it was suspected to be related to the implanted device or the implant procedure.No additional adverse patient effects were reported.Smart registry.

• 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: 7614903
• MDR Text Key: 111520711
• Report Number: 2124215-2018-08230
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• 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
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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: 0692; 4677; G447
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR