MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G125

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045)

Event Date 02/07/2019

Event Type  Death  

Manufacturer Narrative

This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this field clinical representative contacted boston scientific technical services.The technical service consultant was informed that this patient was presented back to the electrophysiology laboratory on (b)(6) 2019 for a scheduled device replacement procedure due to normal battery depletion.The field clinical representative reported that the chronic device was successfully interrogated prior to the start of the replacement procedure.At that time, the patient was stable and had an underlying rhythm.Device function was normal with stable sensing, impedance and thresholds.The pocket was opened and the psa cables were connected to the left ventricular lead.Diagnostic testing of the left ventricular lead was performed which confirmed that the lead was in a stable position.The left ventricular lead was paced asynchronously.The chronic leads were inserted into the ports of the replacement device.It was confirmed that the replacement device was successfully connected to the leads following stable lead diagnostic measurements.During pocket closure, the patient respiratory status started to decline associated with a drop in blood pressure.Emergency intervention including cardiopulmonary resuscitation was initiated.After approximately 30 minutes, the patient could not be stabilized and the patient was pronounced deceased.

• Brand Name: MOMENTUM CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8384868
• MDR Text Key: 137654287
• Report Number: 2124215-2019-03932
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589126
• UDI-Public: 00802526589126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2019
• Device Model Number: G125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 80 YR