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

Model Number G547

Device Problems Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917); High Capture Threshold (3266)

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

It was reported that there were concerns about this cardiac resynchronization therapy defibrillator (crt-d) threshold as it has lowered from implant on the left ventricular (lv) channel.The boston scientific representative noted that they were worried that the lead may have moved.It was noted that the clinic reprogrammed the parameters for this device.The representative wanted to discuss troubleshooting.Ts noted that the thresholds improved.The device will continue to be monitored.The device remains in use.No adverse patient effects were reported.Additional information received indicates that there were concerns this device exhibited loss of capture (loc) on the lv channel during the threshold test as there were high capture thresholds.Technical services (ts) reviewed the reports of the threshold test and noted that there was an intermittently early lv signal that inhibited the lv pace.Ts suspected that the device oversensed a left atrial signal.Ts suggested reprogramming, which resolved the early lv signal from appearing on the electrogram (egm).The device remains in use.No adverse patient effects were reported.

• Brand Name: RESONATE HF 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 55112-5798 ; 6515826168
• MDR Report Key: 18954974
• MDR Text Key: 338475611
• Report Number: 2124215-2024-17322
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589744
• UDI-Public: 00802526589744
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G547
• Device Catalogue Number: G547
• Device Lot Number: 318903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2023
• 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: 69 YR
• Patient Sex: Male