MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G447

Device Problems Failure to Capture (1081); Failure to Read Input Signal (1581); Under-Sensing (1661); Low impedance (2285); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2023

Event Type  malfunction  

Event Description

It was reported that this implantable pacemaker recorded an alert for left ventricular automatic threshold detected as greater than programmed amplitude or suspended due to fusion events.The left ventricular (lv) capture cannot be confirmed on the presenting electrogram (egm).It was recommended to have an assessment performed with a programmer.The lead measurements are stable, and the battery longevity status is normal.At this time, the device remains in service.No adverse patient effects were reported.

Event Description

It was reported that this implantable pacemaker recorded an alert for left ventricular automatic threshold detected as greater than programmed amplitude or suspended due to fusion events.The left ventricular (lv) capture cannot be confirmed on the presenting electrogram (egm).It was recommended to have an assessment performed with a programmer.The lead measurements are stable, and the battery longevity status is normal.Received additional information advising the pacemaker recorded another alert for left ventricular automatic threshold detected as greater than programmed amplitude or suspended due to fusion events.When successful the left ventricular automatic threshold test shows high threshold greater than 3v (volts) and trending shows a decrease in lv pacing impedances still within range.The electrograms (egms) show atrial fibrillation (af) with atrial undersensing observed.Atrial tachy discriminators remain programmed on.Recommended assessment of tachy programming.Received additional information advising the pacemaker recorded two previous alerts for left ventricular automatic threshold detected as greater than programmed amplitude or suspended with atrial undersensing observed.A manual lv threshold tested below programmed output.The patient was recently seen in-clinic and no programming changes were made.Received additional information the atrial intrinsic amplitude is out of range.The presenting egm continues to show undersensing of atrial arrhythmia.Programming sensitivity appears to be known and atrial intrinsic amplitude appears to be off at a clinic level.At this time, the device remains in service.No adverse patient effects were reported.

Event Description

It was reported that this implantable pacemaker recorded an alert for left ventricular automatic threshold detected as greater than programmed amplitude or suspended due to fusion events.The left ventricular (lv) capture cannot be confirmed on the presenting electrogram (egm).It was recommended to have an assessment performed with a programmer.The lead measurements are stable, and the battery longevity status is normal.Received additional information advising the pacemaker recorded another alert for left ventricular automatic threshold detected as greater than programmed amplitude or suspended due to fusion events.When successful the left ventricular automatic threshold test shows high threshold greater than 3v (volts) and trending shows a decrease in lv pacing impedances still within range.The electrograms (egms) show atrial fibrillation (af) with atrial undersensing observed.Atrial tachy discriminators remain programmed on.Recommended assessment of tachy programming.At this time, the device remains in service.No adverse patient effects were reported.

• Brand Name: RESONATE X4 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: 17656655
• MDR Text Key: 322387962
• Report Number: 2124215-2023-47052
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 303550
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 09/28/2023; 12/06/2023
• Supplement Dates FDA Received: 10/24/2023; 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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 Age: 78 YR