MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G158

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) has reached elective replacement indicator (eri) and patient is dependent.This device has lasted only five and a half years.It was also stated that one of the leads exhibited high output.Additional information received which indicated that there was no premature battery depletion (pbd) suspected and field representative did not recall which lead had a higher output.As of this time, this device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) has reached elective replacement indicator (eri) and patient is dependent.This device has lasted only five and a half years.It was also stated that one of the leads exhibited high output.Additional information received which indicated that there was no premature battery depletion (pbd) suspected and field representative did not recall which lead had a higher output.As of this time, this device remains in service.No adverse patient effects were reported.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.Upon receipt at our post market quality assurance laboratory, the device was forwarded to detailed analysis for further investigation.Device never triggered elective replacement indicator (eri) while implanted.The diagnostic data spreadsheet graph shows a cell depletion pattern that is consistent with normal battery depletion.Based on the memory log the device battery voltage was greater than 2.7 volts and the power usage was normal while implanted, all therapy was available while implanted.The no problem detected conclusion code was selected based on analysis of the returned product.Analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) has reached elective replacement indicator (eri) and patient is dependent.This device has lasted only five and a half years.It was also stated that one of the leads exhibited high output.Additional information received which indicated that there was no premature battery depletion (pbd) suspected and field representative did not recall which lead had a higher output.As of this time, this device remains in service.No adverse patient effects were reported.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN X4 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: 16145435
• MDR Text Key: 307673382
• Report Number: 2124215-2023-01080
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2023

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: 05/19/2019
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 171684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 01/25/2023; 06/07/2023
• Supplement Dates FDA Received: 02/08/2023; 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male