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

Model Number G447

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Data Problem (3196)

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

Event Date 04/27/2023

Event Type  Injury  

Event Description

It was reported that a routine follow-up appointment about a month after the implant procedure, this device battery's estimated longevity was noticeably decreased longevity (>8 years to 2 years remaining).The device data was forwarded to technical services and is pending review.At this time, the device remains implanted and in-service.No adverse patient effects were reported.

Event Description

It was reported that a routine follow-up appointment about a month after the implant procedure, this device battery's estimated longevity was noticeably decreased longevity (>8 years to 2 years remaining).The device data was forwarded to technical services and emergent replacement was recommended.It was also recommended to assess the left ventricular (lv) lead, as this device's daily lv pacing impedance measurements reported erroneous values and the device's power usage increased dramatically.The physician subsequently explanted and replaced the device to resolve the event.The replacement device was tested and the lv lead was functioning normally.The patient was stable with no additional adverse effects.The device was received for analysis and is pending the investigation conclusion.Once the analysis is complete, this record will be updated with results.

Event Description

It was reported that a routine follow-up appointment about a month after the implant procedure, this device battery's estimated longevity was noticeably decreased longevity (>8 years to 2 years remaining).The device data was forwarded to technical services and emergent replacement was recommended.It was also recommended to assess the left ventricular (lv) lead, as this device's daily lv pacing impedance measurements reported erroneous values and the device's power usage increased dramatically.The physician subsequently explanted and replaced the device to resolve the event.The replacement device was tested and the lv lead was functioning normally.The patient was stable with no additional adverse effects.The device was received for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the product was performed.Review of device memory confirmed the presence of a higher than normal current drain condition.Electrical testing and analysis were then conducted, which isolated the high current to an anomaly in an oxide layer within a custom integrated circuit component.This anomaly caused a high current drain, which over time resulted in the reported clinical observations.

• 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: 16850315
• MDR Text Key: 314364542
• Report Number: 2124215-2023-20942
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 296573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR