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

Model Number	G156
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Read Input Signal (1581); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that the health care professional (hcp) called for assistance programming this cardiac resynchronization therapy defibrillator (crt-d) and the right ventricular (rv) lead into magnetic resonance imaging (mri) protection mode.Technical services (ts) evaluated this crt-d for programming but didn't program into mri protection mode due to low out of range shock lead impedance measurements of one ohm.Ts recommended evaluating the rv lead and discussed that proceeding with an mri would be non-conditional due to the low shock lead impedance measurement.This crt-d remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information added to b5.
Event or Problem Description
It was reported that the health care professional (hcp) called for assistance programming this cardiac resynchronization therapy defibrillator (crt-d) and the right ventricular (rv) lead into magnetic resonance imaging (mri) protection mode.Technical services (ts) evaluated this crt-d for programming but didn't program into mri protection mode due to low out of range shock lead impedance measurements of one ohm.Ts recommended evaluating the rv lead and discussed that proceeding with an mri would be non-conditional due to the low shock lead impedance measurement.This crt-d remains in service.No additional adverse patient effects were reported.Additional information was received.Ts reviewed device data and found the shock lead impedance has been 0, 8, 11, and 18 ohms.Ts discussed this did not look like normal interference and suspected a possible short.Ts recommended the patient receive a commanded 41j shock test.
Event or Problem Description
It was reported that the health care professional (hcp) called for assistance programming this cardiac resynchronization therapy defibrillator (crt-d) and the right ventricular (rv) lead into magnetic resonance imaging (mri) protection mode.Technical services (ts) evaluated this crt-d for programming but didn't program into mri protection mode due to low out of range shock lead impedance measurements of one ohm.Ts recommended evaluating the rv lead and discussed that proceeding with an mri would be non-conditional due to the low shock lead impedance measurement.This crt-d remains in service.No additional adverse patient effects were reported.Additional information was received.Ts reviewed device data and found the shock lead impedance has been 0, 8, 11, and 18 ohms.Ts discussed this did not look like normal interference and suspected a possible short.Ts recommended the patient receive a commanded 41j shock test.Additional information was received.The rv lead exhibited low amplitudes and noise was suspected.Ts discussed planning a commanded shock to assess lead integrity.
Additional Manufacturer Narrative
Additional information added to b5.B1, b2, h1, f10 and h6 updated.
Event or Problem Description
It was reported that the health care professional (hcp) called for assistance programming this cardiac resynchronization therapy defibrillator (crt-d) and the right ventricular (rv) lead into magnetic resonance imaging (mri) protection mode.Technical services (ts) evaluated this crt-d for programming but didn't program into mri protection mode due to low out of range shock lead impedance measurements of one ohm.Ts recommended evaluating the rv lead and discussed that proceeding with an mri would be non-conditional due to the low shock lead impedance measurement.This crt-d remains in service.No additional adverse patient effects were reported.Additional information was received.Ts reviewed device data and found the shock lead impedance has been 0, 8, 11, and 18 ohms.Ts discussed this did not look like normal interference and suspected a possible short.Ts recommended the patient receive a commanded 41j shock test.Additional information was received.The rv lead exhibited low amplitudes and noise was suspected.Ts discussed planning a commanded shock to assess lead integrity.Additional information was received.A defibrillation threshold (dft) test was performed and was successful.The physician planned to monitor the patient.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN? X4 CRT-D
• Common Device Name: 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: 23918174
• Report Number: 2124215-2025-93586
• Device Sequence Number: 9147845
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: (01)00802526534669(17)190721
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/08/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/21/2019
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 377508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 03/30/2026; 04/10/2026; 05/05/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 04/02/2026; 04/16/2026; 05/08/2026
• Date Device Manufactured: 08/04/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male