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

Model Number G158

Device Problems Failure to Capture (1081); Pacing Problem (1439); Under-Sensing (1661); Low impedance (2285)

Patient Problems Asystole (4442); Twiddlers Syndrome (4563); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2022

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) remote communicator displayed a red call doctor icon.The crt-d was having difficulty completing a remote interrogation.It was indicated that the communicator was unplugged.The patient was referred to contact their clinic regarding the red call doctor icon.At this time, this device remains in service and there were no adverse patient effects reported.Additional information received indicated that there is no official red call doctor, however, low out of range pacing impedance measurements on the right ventricular (rv) lead was determined.Technical services (ts) indicated that the red call doctor icon did not display due to this patient was seen and interrogated in the clinic with a programmer before the latitude interrogation.

Manufacturer Narrative

Should additional information be provided, a supplemental report will be submitted.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) remote communicator displayed a red call doctor icon.The crt-d was having difficulty completing a remote interrogation.It was indicated that the communicator was unplugged.The patient was referred to contact their clinic regarding the red call doctor icon.At this time, this device remains in service and there were no adverse patient effects reported.Additional information received indicated that there is no official red call doctor, however, the right ventricular (rv) lead exhibited low, out-of-range pace impedance measurements of less than 200 ohms, loss of capture with asystole, undersensing with a delay in the therapy of less than thirty seconds and pacing not being delivered when required.Boston scientific technical services (ts) was contacted, and ts confirmed the low impedance measurements and discussed options.Additionally, ts indicated that the red call doctor icon did not display due to this patient was seen and interrogated in the clinic with a programmer before the latitude interrogation.Subsequently, the patient underwent a revision procedure and the rv lead was replaced.The right atrial (ra) lead was also replaced due to loss of capture, functional undersensing, and pacing not being delivered when required.It was noted that the lead malfunctions were the result of twiddler's syndrome.The crt-d remains in service.No additional adverse patient effects were reported.

• 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: 14212140
• MDR Text Key: 290103907
• Report Number: 2124215-2022-13323
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/27/2021
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 212729
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2019
• 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; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female