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

Model Number G547

Device Problems Premature Discharge of Battery (1057); Failure to Capture (1081); Use of Device Problem (1670); Low impedance (2285); Battery Problem (2885); High Capture Threshold (3266)

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

Event Date 07/06/2023

Event Type  Injury  

Event Description

It was reported that the battery of this recently implanted cardiac resynchronization therapy defibrillator (crt-d) was suspected to be depleting prematurely as a recent longevity estimate indicated approximately two years remaining.It was noted that the right ventricular (rv) lead threshold measurement at implant was 0.4v@0.4ms.At this time, right ventricular autothreshold (rvat) testing was in suspension, right ventricular autocapture (rvac) was unavailable, and rv outputs were 5.0v @ 0.4ms.In addition, rv impedance measurements were low and have been trending downward since implant.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.This crt-d system remains in service, however urgent device replacement was recommended.This patient is not pacer dependent, and no adverse patient effects were reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that the battery of this recently implanted cardiac resynchronization therapy defibrillator (crt-d) was suspected to be depleting prematurely as a recent longevity estimate indicated approximately two years remaining.It was noted that the right ventricular (rv) lead threshold measurement at implant was 0.4v@0.4ms.At this time, right ventricular auto threshold (rvat) testing was in suspension, right ventricular autocapture (rvac) was unavailable, and rv outputs were 5.0v @ 0.4ms.In addition, rv impedance measurements were low and have been trending downward since implant.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.This crt-d system remains in service, however urgent device replacement was recommended.This patient is not pacer dependent, and no adverse patient effects were reported.Additional information received reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted, replaced, and returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.The product has been received for analysis.This report will be updated upon completion of 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.

Event Description

It was reported that the battery of this recently implanted cardiac resynchronization therapy defibrillator (crt-d) was suspected to be depleting prematurely as a recent longevity estimate indicated approximately two years remaining.It was noted that the right ventricular (rv) lead threshold measurement at implant was 0.4v@0.4ms.At this time, right ventricular autothreshold (rvat) testing was in suspension, right ventricular autocapture (rvac) was unavailable, and rv outputs were 5.0v @ 0.4ms.In addition, rv impedance measurements were low and have been trending downward since implant.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.This crt-d system remains in service, however urgent device replacement was recommended.This patient is not pacer dependent, and no adverse patient effects were reported.Additional information received reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted, replaced, and returned for analysis.No additional adverse patient effects were reported.

• Brand Name: RESONATE HF 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: 17355932
• MDR Text Key: 319559120
• Report Number: 2124215-2023-38225
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G547
• Device Catalogue Number: G547
• Device Lot Number: 301787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female