MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G447

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Electric Shock (2554)

Event Date 10/02/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system had a commanded shock that revealed that this code 1005 indicative of an open circuit condition during shock delivery.A gradual increase in shock impedance had been previously noticed, calcification was suspected.Technical services (ts) was consulted, reviewed reasons for the exhibited code and recommended lead replacement.This crt-d system remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system had a commanded shock that revealed that this code 1005 indicative of an open circuit condition during shock delivery.A gradual increase in shock impedance had been previously noticed, calcification was suspected.Technical services (ts) was consulted, reviewed reasons for the exhibited code and recommended lead replacement.This crt-d system remains in service.No additional adverse patient effects were reported.Additional information was received and this crt-d and right ventricular (rv) lead were explanted and replaced.The product has not returned for analysis.No additional adverse patient effects were reported.The device was not returned by the customer, therefore, no product analysis could be performed.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 17940101
• MDR Text Key: 325740969
• Report Number: 2124215-2023-57141
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: 00802526589539
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2023

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 Expiration Date: 06/01/2021
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 217384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2019
• 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; Other; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female