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); Battery Problem (2885)

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

Event Date 04/08/2024

Event Type  Injury  

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 cardiac resynchronization therapy defibrillator (crt-d) was suspected to be depleting prematurely, and the right ventricular (rv) lead exhibited low pace impedance measurements less than 200 ohms.While in-clinic, a longevity calculation of this crt-d indicated 7 months remaining battery life after less than 7 months of 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 premature battery depletion (pbd) was likely related to the rv pace channel and indicative of an anomaly in the oxide layer of the rv pace hardware with potential for lead corrosion damage.As a result, device replacement and rv lead replacement were recommended.This crt-d system remains in service at this time, and no adverse patient effects were reported.

Event Description

It was reported that the battery of this cardiac resynchronization therapy defibrillator (crt-d) was suspected to be depleting prematurely, and the right ventricular (rv) lead exhibited low pace impedance measurements less than 200 ohms.While in-clinic, a longevity calculation of this crt-d indicated 7 months remaining battery life after less than 7 months of 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 premature battery depletion (pbd) was likely related to the rv pace channel and indicative of an anomaly in the oxide layer of the rv pace hardware with potential for lead corrosion damage.As a result, device replacement and rv lead replacement were recommended.This crt-d system remains in service at this time, and no adverse patient effects were reported.Additional information received reported that the cardiac resynchronization therapy defibrillator (crt-d) was explanted, replaced, and returned for analysis.The right ventricular (rv) lead remains in service.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.

Event Description

It was reported that the battery of this cardiac resynchronization therapy defibrillator (crt-d) was suspected to be depleting prematurely, and the right ventricular (rv) lead exhibited low pace impedance measurements less than 200 ohms.While in-clinic, a longevity calculation of this crt-d indicated 7 months remaining battery life after less than 7 months of 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 premature battery depletion (pbd) was likely related to the rv pace channel and indicative of an anomaly in the oxide layer of the rv pace hardware with potential for lead corrosion damage.As a result, device replacement and rv lead replacement were recommended.This crt-d system remains in service at this time, and no adverse patient effects were reported.Additional information received reported that the cardiac resynchronization therapy defibrillator (crt-d) was explanted, replaced, and returned for analysis.The right ventricular (rv) lead remains in service.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.Correction to h6: impact coding updated to reflect device changeout.

• 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: 19177352
• MDR Text Key: 341421548
• Report Number: 2124215-2024-24967
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 313075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 04/30/2024; 04/30/2024
• Supplement Dates FDA Received: 05/10/2024; 05/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/19/2023
• 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: 60 YR
• Patient Sex: Male