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

Model Number G138

Device Problems Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Arrhythmia (1721); Anxiety (2328); Electric Shock (2554)

Event Date 06/10/2022

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was found to be in safety mode.The patient reported that due to a complicated heart rate management for recurrent non sustained ventricular tachycardia (vt) and a replacement of a mitral valve, the situation rapidly worsened and had to be rushed to hospital where it could not be diagnose due to lack of electro physiologists over weekend.The patient had to be drugged for four days to stabilize the heart arrhythmia which was worsened by constant pacing.The patient had to lay in the same position, as sitting up stopped the device from pacing.The patient got inappropriately shocked six times over that period.The device was subsequently explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Correction: codes e020201 and e0601 added.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was found to be in safety mode.The patient reported that due to a complicated heart rate management for recurrent non sustained ventricular tachycardia (vt) and a replacement of a mitral valve, the situation rapidly worsened and had to be rushed to hospital where it could not be diagnose due to lack of electro physiologists over weekend.The patient had to be drugged for four days to stabilize the heart arrhythmia which was worsened by constant pacing.The patient had to lay in the same position, as sitting up stopped the device from pacing and was reported very distressful.The patient got inappropriately shocked six times over that period.The device was subsequently explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM 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
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15173165
• MDR Text Key: 297312254
• Report Number: 2124215-2022-29171
• Device Sequence Number: 1
• Product Code: NIK
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G138
• Device Catalogue Number: G138
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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