MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; IMPLANTABLE DEFIBRILLATOR

Model Number G151

Device Problems Device Alarm System (1012); Failure to Capture (1081); High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Capture Threshold (3266)

Patient Problem Electric Shock (2554)

Event Date 04/08/2022

Event Type  Injury  

Event Description

It was reported that patient called stating flashing red call doctor icon appeared briefly on communicator last night, rebooted and went back to green.Discussed general communicator functions and scheduling.Reboot communicator may have been flashing yellow call doctor icon and communicator status is monitored.A boston scientific company representative informed patient if red call doctor icon persisted after having power cycle to refer to clinic for discussion.No adverse patient effects were report.Additional information clarified that a commanded shock was performed and this implantable cardioverter defibrillator displayed a code 1005 indicative of an open circuit condition detected during shock delivery.Replacement of the lead was discussed.At this moment this device remains in service.No further adverse patient effects were reported.

Manufacturer Narrative

Additional information was added to the following fields: b5: describe event or problem field, h6: impact codes.

Event Description

It was reported that patient called stating flashing red call doctor icon appeared briefly on communicator last night, rebooted and went back to green.Discussed general communicator functions and scheduling.Reboot communicator may have been flashing yellow call doctor icon and communicator status is monitored.A boston scientific company representative informed patient if red call doctor icon persisted after having power cycle to refer to clinic for discussion.No adverse patient effects were report.Additional information clarified that a commanded shock was performed and this implantable cardioverter defibrillator displayed a code 1005 indicative of an open circuit condition detected during shock delivery.Replacement of the lead was discussed.At this moment this device remains in service.No further adverse patient effects were reported.Additional information was received detailing that high pacing thresholds were also observed on the right ventricular channel and loss of capture on the left ventricular channel.The tachy therapy of the device was turned off.

Event Description

It was reported that patient called stating flashing red call doctor icon appeared briefly on communicator last night, rebooted and went back to green.Discussed general communicator functions and scheduling.Reboot communicator may have been flashing yellow call doctor icon and communicator status is monitored.A boston scientific company representative informed patient if red call doctor icon persisted after having power cycle to refer to clinic for discussion.No adverse patient effects were report.Additional information clarified that a commanded shock was performed and this implantable cardioverter defibrillator displayed a code 1005 indicative of an open circuit condition detected during shock delivery.Replacement of the lead was discussed.At this moment this device remains in service.No further adverse patient effects were reported.Additional information was received detailing that high pacing thresholds were also observed on the right ventricular channel and loss of capture on the left ventricular channel.The tachy therapy of the device was turned off.Additional information was received detailing that audible tones were heard from this device, since the therapy has been turned off the root cause of this could not be established.Further evaluation of the patient and an in person evaluation were discussed.This device remains in service.

Manufacturer Narrative

Additional information was added to the following fields: b2: outcome attributed to adverse event, b5: describe event or problem field, d6b: explant date, h6: impact codes.Additional information was added to the following fields: b5: describe event or problem field, h6: device codes.Additional information was added to the following fields: b5: describe event or problem field, h6: impact codes.

Event Description

It was reported that patient called stating flashing red call doctor icon appeared briefly on communicator last night, rebooted and went back to green.Discussed general communicator functions and scheduling.Reboot communicator may have been flashing yellow call doctor icon and communicator status is monitored.A boston scientific company representative informed patient if red call doctor icon persisted after having power cycle to refer to clinic for discussion.No adverse patient effects were report.Additional information clarified that a commanded shock was performed and this implantable cardioverter defibrillator displayed a code 1005 indicative of an open circuit condition detected during shock delivery.Replacement of the lead was discussed.At this moment this device remains in service.No further adverse patient effects were reported.Additional information was received detailing that high pacing thresholds were also observed on the right ventricular channel and loss of capture on the left ventricular channel.The tachy therapy of the device was turned off.Additional information was received detailing that audible tones were heard from this device, since the therapy has been turned off the root cause of this could not be established.Further evaluation of the patient and an in person evaluation were discussed.This device remains in service.Additional information was received detailing that this device was explanted.No further adverse patient effects were reported.

• Brand Name: DYNAGEN CRT-D
• Type of Device: IMPLANTABLE 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: 14504602
• MDR Text Key: 292704675
• Report Number: 2124215-2022-17462
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/19/2024

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: 12/18/2018
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 119524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 07/21/2023; 12/22/2023; 03/06/2024
• Supplement Dates FDA Received: 08/11/2023; 01/11/2024; 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2017
• 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): Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Male