MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D DF1/IS4 G138; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DF/IS4 G138

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 06/10/2022

Event Type  Injury  

Event Description

My crt icd device developed a safety mode error.As i have complicated heart rate management for recurrent non sustained vt and replacement mitral valve.I rapidly became very unwell and had to be rushed to hospital where they couldn't diagnose the problem due to lack of electro physiologists over weekend.Due to my regular vt episodes i had to be drugged for 4 days to stabilize heart arrhythmia which was worsened by constant pacing.I had to lay in the same position as sitting up stopped the device pacing and i got shocked.Over the period i had 6 fully conscious inappropriate shocks which was highly distressing since after 16 years of having an icd.I have never experienced one since the settings were previous to the fault set purposefully with a high threshold and trigger time.Fda safety report id # (b)(4).

• Brand Name: MOMENTUM CRT-D DF1/IS4 G138
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 15077649
• MDR Text Key: 296403960
• Report Number: MW5111020
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DF/IS4 G138
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization; Other; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male