MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; IMPLANTABLE DEFIBRILLATOR

Model Number G154

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Ventricular Tachycardia (2132)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

The device remains implanted.At this time, no further information is expected.This investigation will be updated should further information be provided.

Event Description

It was reported that this patient experienced multiple long events of arrhythmia in which the ventricular rate was hovering above and below the ventricular tachycardia (vt) rate cutoff which caused episodes to end and restart in the device logbook.This lead to anti-tachycardia pacing (atp) being delivered repeatedly without progressing to a tachy shock in most cases and preventing the delivery of critical therapy during one vt episode.Boston scientific technical services suggested programming changes.No adverse events were reported.

• Brand Name: DYNAGEN CRT-D
• Type of Device: IMPLANTABLE DEFIBRILLATOR
• 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: 8772283
• MDR Text Key: 150436893
• Report Number: 2124215-2019-13204
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: 00802526534652
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/02/2020
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 103249
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR