MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND DYNAGEN; IMPLANTABLE CHF GENERATOR

Model Number G150

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

Patient Problems Death (1802); High Blood Pressure/ Hypertension (1908); Pulmonary Edema (2020); Respiratory Failure (2484)

Event Date 11/07/2016

Event Type  Death  

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 during the implant of this cardiac resynchronization therapy defibrillator (crt-d) the patient's blood pressure and oxygen saturation dropped while the leads were being sutured.The patient was intubated and conscious sedation was reversed.An echocardiogram was performed and no evidence of fluid was found.The patient's heart rate was noted to be 115 to 120 beats per minute (bpm) and their blood pressure increased.The implant was completed with three zones programmed and no defibrillation threshold (dft) testing.Good sensing, threshold, and impedance measurements were obtained.The patient was extubated and moved to recovery.It was noted the patient's blood pressure remained high.The patient again required intubation.Shortly after the local representative was paged to programmed the device off and the patient expired.The cause of death was determined to be hypertensive crisis, acute pulmonary edema, and respiratory failure hypercapnic.

• Brand Name: DYNAGEN
• Type of Device: IMPLANTABLE CHF GENERATOR
• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6110439
• MDR Text Key: 60248030
• Report Number: 2124215-2016-19341
• Device Sequence Number: 1
• Product Code: NIK
• 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: 11/07/2016

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: 08/17/2018
• Device Model Number: G150
• Other Device ID Number: DYNAGEN CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2016
• 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: 0293; 4088; 4543; G150
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Weight: 104