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 Low Blood Pressure/ Hypotension (1914); Heart Failure (2206); Cardiogenic Shock (2262)

Event Date 09/09/2017

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 implanted with this cardiac resynchronization therapy defibrillator (crt-d) and a competitor left ventricular (lv) lead went into cardiogenic shock one day following an lv lead revision and normal generator replacement procedure.The patient developed hypotension and acute heart failure resulting in prolonged hospital stay.While hospitalized, the patient received intravenous medications and underwent diagnostic evaluations through an echocardiogram and cbc lab tests.The patient was discharged home eleven days later.No further issues have been 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: 6935830
• MDR Text Key: 89116791
• Report Number: 2124215-2017-18150
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/27/2019
• Device Model Number: G247
• Other Device ID Number: VIGILANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR