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

Model Number G247

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Swelling (2091); Tachycardia (2095); Thrombosis (2100); Complaint, Ill-Defined (2331)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

No further information concerning this report is available at this time.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this patient awoke out of deep sleep, coughing, heart racing around 110 bpm and blood pressure 220/110.Patient was incontinent.Device was interrogated.Patient reported site infection, cellulites, swelling in arm, blood clot and site, felt like brick on site.Patient on antibiotics.Patient requested information about device and others.Response explained device function, testing, therapies, diagnostics and lead evaluations.Referred to physician.Remains in service.No additional adverse patient effects were reported.

• Brand Name: VIGILANT
• 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: 8028853
• MDR Text Key: 125820779
• Report Number: 2124215-2018-19282
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2020
• Device Model Number: G247
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2018
• 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: 0292; 4677; 7740; G247
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 62 YR