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

Model Number G151

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Ventricular Fibrillation (2130)

Event Date 01/21/2022

Event Type  Injury  

Event Description

It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) presented after receiving a shock.Review of the store episodes found anti-tachycardia pacing (atp) had been delivered along with three shocks.Atp was not effective in converting the arrhythmia and rhythm acceleration was noted after which a shock was delivered.The patient remained in a slow ventricular tachycardia (vt) below the detect rate.It was reported that the patient in on the heart transplant list and had been externally shocked three times since presenting.However, after successful conversion the patient goes back into a ventricular arrhythmia.Amiodarone was administer and further consultation with cardiology was planned.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN 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 CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13910629
• MDR Text Key: 288034970
• Report Number: 2124215-2022-04512
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 00802526534638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/29/2017
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 111121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• 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): Life Threatening; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male