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

Model Number G126

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Connection Problem (2900)

Patient Problem Electric Shock (2554)

Event Date 09/15/2023

Event Type  Injury  

Event Description

It was reported that a follow-up appointment, it was noted that the shock impedance measurement from the right ventricular (rv) lead was greater than 200 ohms in every position.The patient was hospitalized and a lead revision was attempted, but the subclavian vein was inaccessible so the physician aborted the procedure.The device data was forwarded to boston scientific technical services (ts) for review.Commanded shock testing was discussed to verify the shock impedance for a delivered shock.Additionally, the physician inquired the possibility of implanting a subcutaneous implantable cardiac defibrillator (s-icd) system in conjunction with the currently implanted cardiac resynchronization therapy defibrillator (crt-d) system.However, the patient did not pass the s-icd screening and ts stated that a s-icd system would not be recommended alongside the current need for left ventricular pacing.Diagnostic imaging was performed to verify the lead connections prior to commanded shock testing, but the physician was unable to conclusively determine an appropriate connection.Therefore, another surgical procedure was performed where the physician re-screwed the leads securely back into the header.However, when 1.1 joule and 41 joule shocks were delivered, a code 1005 appeared, indicating an open circuit condition.This information was forwarded to ts and a rv lead replacement procedure was strongly recommended to ensure effective shock delivery.At this time, the device and rv lead remain implanted and in-service.The patient is stable.

Event Description

It was reported that a follow-up appointment, it was noted that the shock impedance measurement from the right ventricular (rv) lead was greater than 200 ohms in every position.The patient was hospitalized and a lead revision was attempted, but the subclavian vein was inaccessible so the physician aborted the procedure.The device data was forwarded to boston scientific technical services (ts) for review.Commanded shock testing was discussed to verify the shock impedance for a delivered shock.Additionally, the physician inquired the possibility of implanting a subcutaneous implantable cardiac defibrillator (s-icd) system in conjunction with the currently implanted cardiac resynchronization therapy defibrillator (crt-d) system.However, the patient did not pass the s-icd screening and ts stated that a s-icd system would not be recommended alongside the current need for left ventricular pacing.Diagnostic imaging was performed to verify the lead connections prior to commanded shock testing, but the physician was unable to conclusively determine an appropriate connection.Therefore, another surgical procedure was performed where the physician re-screwed the leads securely back into the header.However, when 1.1 joule and 41 joule shocks were delivered, a code 1005 appeared, indicating an open circuit condition.This information was forwarded to ts and a rv lead replacement procedure was strongly recommended to ensure effective shock delivery.At this time, the device and rv lead remain implanted and in-service.The patient is stable.It was stated that due to clinical reasons, the physician elected not to perform surgical intervention and is continuing with close monitoring.

• Brand Name: MOMENTUM 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: 17844750
• MDR Text Key: 324605633
• Report Number: 2124215-2023-53798
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

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 Expiration Date: 11/20/2021
• Device Model Number: G126
• Device Catalogue Number: G126
• Device Lot Number: 104721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR