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

Model Number G154

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had entered safety mode and had required three resets to obtain this status.This device was not implanted; no patient involvement reported.

Manufacturer Narrative

Correction: b5 updated for clarity.Upon receipt at our post market quality assurance laboratory, the device was confirmed to be operating in safety mode as was reported from the field.Memory review confirmed that the device underwent a reset due to memory corruption.A memory error was recorded on september 15, 2020 followed by three device faults.It is normal device function for this product to revert to safety mode after detecting three faults in a short period of time.The device reverted to a safety mode with limited programmability, in which single chamber pacing and defibrillation therapy were available.Detailed analysis determined the root cause of the memory corruption appeared to be due to an issue with a digital integrated circuit component.The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that upon device interrogation prior to implant, this cardiac resynchronization therapy defibrillator (crt-d) had entered safety mode.This device was not implanted and was returned for analysis.

• 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: 11182967
• MDR Text Key: 227553354
• Report Number: 2124215-2020-28125
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: 00802526534652
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/28/2022
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 105148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2020
• 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