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

Model Number G158

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586)

Patient Problem Electric Shock (2554)

Event Date 05/10/2022

Event Type  Injury  

Manufacturer Narrative

If the product is returned, analysis would be performed and this report would be updated at that time.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded code 1007, message indicator that the shocking capacitors are not charged to the programmed voltage 45 seconds after the start of charging.Reportedly, the patient was received at the emergency room due to multiple shocks of atrial fibrillation with rapid ventricular response that exhausted the therapy.Technical services reviewed the case and indicated the issue could be related to an open circuit condition on the right ventricular (rv) lead.It was recommended to replace immediately this crt-d and the rv lead if the open circuit is confirmed.Subsequently, this crt-d was explanted, replaced and it is not expected to be returned for analysis.Reportedly, the shorted lead condition was discarded after the device data was remotely analyzed by engineering.The rv lead was working adequately.It appears that the device lost the ability to charge due to some other cause.No additional adverse patient effects were reported.

Manufacturer Narrative

If the product is returned, analysis would be performed and this report would be updated at that time.Upon receipt at our post market quality assurance laboratory, the cardiac resynchronization therapy defibrillator (crt-d) was thoroughly inspected and analyzed.Visual inspection found no anomalies.This product was put through and passed the returned products test, which involves a series of automated diagnostic testing that verifies the performance of pacing, sensing, shocking and recording functions of the device commensurate with battery voltage.The laboratory 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) recorded code 1007, message indicator that the shocking capacitors are not charged to the programmed voltage 45 seconds after the start of charging.Reportedly, the patient was received at the emergency room due to multiple shocks inappropriately given due to atrial fibrillation with rapid ventricular response that exhausted the therapy.Technical services reviewed the case and indicated the issue could be related to an open circuit condition on the right ventricular (rv) lead.It was recommended to replace immediately this crt-d and the rv lead if the open circuit is confirmed.Subsequently, this crt-d was explanted, replaced and was returned for analysis.Reportedly, the shorted lead condition was discarded after the device data was remotely analyzed by engineering.The rv lead was working adequately.It appears that the device lost the ability to charge due to some other cause.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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: 14537573
• MDR Text Key: 292973778
• Report Number: 2124215-2022-17220
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

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: 06/26/2020
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 195115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 05/28/2022
• Supplement Dates Manufacturer Received: 05/08/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female