MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G156

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581); Ambient Noise Problem (2877); Device Sensing Problem (2917)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2018

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that noise was noted on the right ventricular (rv) and shock channels of this cardiac resynchronization therapy defibrillator (crt-d).Rv oversensing of the noise led to pacing inhibition lasting longer than two seconds.Device sensing was adjusted which appeared to resolve the issue.It was later reported that rv lead amplitudes were out of range.Boston scientific technical services (ts) discussed that this could be due to premature ventricular contractions (pvcs).Ts discussed programming optimization options.No adverse patient effects were reported.This device remains in service.

Event Description

Additional information was reported indicating that the non-boston scientific (bsc) right ventricular (rv) lead started having noise in october 2017.The rv lead was later abandoned surgically and replaced; however, the new rv lead was placed in an area of the heart that was developing exit block.The non-bsc lead was then uncapped and used as the pace/sense portion, and a new high voltage lead was implanted.It was originally thought that this cardiac resynchronization therapy defibrillator (crt-d) was the cause to the noise oversensing and pacing inhibition.The non-bsc rv lead was still having pauses, despite programming changes and was planned to be revised.No additional adverse patient effects were reported.This product remains in service.This report will be updated, should additional information be received.

Event Description

Boston scientific received information that noise was noted on the right ventricular (rv) lead.Oversensing of the noise led to pacing inhibition lasting longer than two seconds.Device sensing was adjusted which appeared to resolve the issue.It was later reported that rv amplitudes were out of range.Technical services discussed that this could be due to premature ventricular contractions.Technical services discussed programming optimization options.No adverse patient effects were reported.This product remains in service.Additional information was reported indicating that the non-boston scientific (bsc) right ventricular (rv) lead started having noise in (b)(6) 2017.It was originally thought that this cardiac resynchronization therapy defibrillator (crt-d) was the cause to the noise oversensing and pacing inhibition.The non-bsc rv lead was later abandoned surgically and replaced; however, the new rv lead was placed in an area of the heart that was developing exit block.The non-bsc lead was then uncapped and used as the pace/sense portion, and a new high voltage lead was implanted.The non-bsc rv lead was still having pauses, despite programming changes and was planned to be revised.No adverse patient effects were reported.This crt-d remains in service.This report will be updated, should additional information be received.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 7981650
• MDR Text Key: 124267322
• Report Number: 2124215-2018-17935
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: 00802526534669
• 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,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/06/2018
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 374823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• 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
• Treatment: 0181.; 0293.; 4674.; G148.; G156.; MISMATCH.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male