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

Model Number G150

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

Patient Problems Pain (1994); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was found to be in safety mode on interrogation.Technical services (ts) recommended device replacement.This device has been explanted and replaced with a new crt-d.No additional adverse patient effects were reported.This product is expected to be returned to boston scientific for investigation.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was found to be in safety mode on interrogation.Technical services (ts) recommended device replacement.This device has been explanted and replaced with a new crt-d.No additional adverse patient effects were reported.This product is expected to be returned to boston scientific for investigation.According to additional information, this patient experienced pain and discomfort prior to explant procedure.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was found to be in safety mode on interrogation.Technical services (ts) recommended device replacement.This device has been explanted and replaced with a new crt-d.No additional adverse patient effects were reported.This product is expected to be returned to boston scientific for investigation.According to additional information, this patient experienced pain and discomfort prior to explant procedure.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that both brady and tachycardia therapy remained available.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.

• 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: 17920587
• MDR Text Key: 325497572
• Report Number: 2124215-2023-56517
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534614
• UDI-Public: 00802526534614
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2024

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: 07/26/2019
• Device Model Number: G150
• Device Catalogue Number: G150
• Device Lot Number: 487622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 10/17/2023; 03/26/2024
• Supplement Dates FDA Received: 10/23/2023; 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• 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): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female