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

Model Number G124

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Defibrillation/Stimulation Problem (1573); Delayed Charge Time (2586)

Patient Problem Electric Shock (2554)

Event Date 12/09/2022

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) was evaluated in the hospital due to an episode of atrial fibrillation (af).The physician decided to perform a manual shock but was unsuccessful.Upon device interrogation, a code 1004 indicative of a short circuit condition, was displayed.Therapy was delivered with an external defibrillator.After this, this device displayed a code 1006, indicative of high voltage detected on lead during charge.Further device interrogation was performed the following day and the battery of this device was found to be at end of life (eol).A device changeout procedure was scheduled and this device and right ventricular (rv) lead were explanted and replaced.No additional adverse patient effects were reported.It is expected to receive these products for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection of the device identified no anomalies.Review of device memory found a shorted lead error had been recorded.Memory also showed that after three shocks had been attempted and resulted in abnormal shock impedance measurements, the device battery status moved to elective replacement indicator (eri) and end of life (eol) due to long charge times.An x ray of the device revealed that the internal high voltage fuse was damaged (i.E., no longer intact).The damage to the fuse most likely occurred during delivery of the shock that resulted in the shorted lead error.The damage to the high voltage fuse prevented any subsequent charging of the high voltage capacitors and delivery of shock therapy.As a result, the third high voltage charge attempt caused the device to declare eol because it could not successfully complete charging within 30 seconds, despite the fact that significant battery voltage and capacity remained.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) was evaluated in the hospital due to an episode of atrial fibrillation (af).The physician decided to perform a manual shock but was unsuccessful.Upon device interrogation, a code 1004 indicative of a short circuit condition, was displayed.Therapy was delivered with an external defibrillator.After this, this device displayed a code 1006, indicative of high voltage detected on lead during charge.Further device interrogation was performed the following day and the battery of this device was found to be at end of life (eol).A device changeout procedure was scheduled and this device and right ventricular (rv) lead were explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM 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: 16017408
• MDR Text Key: 305837608
• Report Number: 2124215-2022-53930
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589102
• UDI-Public: 00802526589102
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/10/2021
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 495349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2019
• 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; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male