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

Model Number G151

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Convert Rhythm (1540); Device Displays Incorrect Message (2591)

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

Event Date 07/31/2018

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, during a device change out procedure, the right ventricular (rv) lead was connected to this new cardiac resynchronization therapy defibrillator (crt-d) and an alert for high out of range shock impedances was observed.The values were greater than 200 ohms.The physician then performed a commanded shock and a code 1005 indicative of a shock lead open condition triggered.The physician elected to continue to monitor the patient as the patient's ejection fraction has increased and with their previous device, they had not received any therapy.The procedure concluded and the system remains in service.No additional adverse patient effects were reported.

Event Description

Boston scientific received information that, during a device change out procedure, the right ventricular (rv) lead was connected to this new cardiac resynchronization therapy defibrillator (crt-d) and an alert for high out of range shock impedances was observed.The values were greater than 200 ohms.The physician then performed a commanded shock and a code 1005 indicative of a shock lead open condition triggered.The physician elected to continue to monitor the patient as the patient's ejection fraction has increased and with their previous device, they had not received any therapy.The procedure concluded and the system remains in service.No additional adverse patient effects were reported.It was reported that the patient was seen and noninvasive programmed stimulation (nips) was performed.Daily measurements showed shock impedance measurements to be 107 ohms in triad.The patient was noted to have been lost to follow up for some time.An arrhythmia was successfully induced during testing, however, the device was unsuccessful in converting the rhythm and the patient was externally rescued.Surgical intervention was undertaken one week later.This cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced and the right ventricular (rv) defibrillation lead was surgically abandoned and replaced.No additional adverse patient effects were reported.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

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.Pin gage testing, designed to verify proper port dimensions, 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.

Event Description

Boston scientific received information that, during a device change out procedure, the right ventricular (rv) lead was connected to this new cardiac resynchronization therapy defibrillator (crt-d) and an alert for high out of range shock impedances was observed.The values were greater than 200 ohms.The physician then performed a commanded shock and a code 1005 indicative of a shock lead open condition triggered.The physician elected to continue to monitor the patient as the patient's ejection fraction has increased and with their previous device, they had not received any therapy.The procedure concluded and the system remains in service.No additional adverse patient effects were reported.It was reported that the patient was seen and noninvasive programmed stimulation (nips) was performed.Daily measurements showed shock impedance measurements to be 107 ohms in triad.The patient was noted to have been lost to follow up for some time.An arrhythmia was successfully induced during testing, however, the device was unsuccessful in converting the rhythm and the patient was externally rescued.Surgical intervention was undertaken one week later.This cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced and the right ventricular (rv) defibrillation lead was surgically abandoned and replaced.No additional adverse patient effects were reported.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

• 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: 7979887
• MDR Text Key: 124168932
• Report Number: 2124215-2018-17636
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 00802526534638
• 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: 04/02/2022

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: 02/26/2020
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 126763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 06/30/2021; 03/16/2022
• Supplement Dates FDA Received: 07/22/2021; 04/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2018
• 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: 0185.; 4064.; 4555.; G151.; H170.; N119.; 0185; 4064; 4555; G151; H170; N119
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male