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

Model Number G126

Device Problems Signal Artifact/Noise (1036); Premature Discharge of Battery (1057); Failure to Capture (1081); Over-Sensing (1438); Low impedance (2285); Defective Device (2588); Battery Problem (2885); Impedance Problem (2950)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2024

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited low out of range pace impedance measurements on the right atrial (ra) lead.As a result, a signal artifact monitor (sam) episode was stored with a vector switch.Boston scientific technical services (ts) also noted that noise was present on the ra as well as the right ventricular (rv) lead and left ventricular (lv) lead.Additionally, atrial signals were oversensed by the rv.According to the field presentative, an ra lead revision has been scheduled in the upcoming weeks.No adverse patient effects were reported.At this time, this device system remains in service.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited low out of range pace impedance measurements on the right atrial (ra) lead.As a result, a signal artifact monitor (sam) episode was stored with a vector switch.Boston scientific technical services (ts) also noted that noise was present on the ra as well as the right ventricular (rv) lead and left ventricular (lv) lead.Additionally, atrial signals were oversensed by the rv.According to the field presentative, an ra lead revision has been scheduled in the upcoming weeks.Further information was received that a revision procedure was performed and the ra lead was surgically abandoned and replaced.Additional information was received that the battery of this device was suspected to be depleting prematurely.Ts calculated the battery longevity on current programmed settings and discussed it should be 8.5 years and the device is indicating 1.5 years to explant.Additionally, the power consumption of the device was found to be excessively high.A request was made to have data from this device analyzed.Data analysis confirmed the device to be malfunctioning in a manner consistent with a failure of the ra pacing channel.Multiple "leadimpcalnoise" daily ra measures, low ra measures and extreme power consumption were observed.Device replacement was recommended due to risk of damaging the pacing lead due to corrosion from current leakage.Upon further evaluation, the hcp suspected loss of capture (loc) in the newly implanted ra lead.Ts discussed testing it on the pacing system analyzer (psa) to determine if the issue was with the pg or if the lead had been damaged.A device changeout procedure was performed and it was confirmed the ra lead exhibited loc on this device, the psa and the new can, therefore, the physician explanted and replaced the ra lead and this device.No additional adverse patient effects were reported.This product has been received for analysis.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited low out of range pace impedance measurements on the right atrial (ra) lead.As a result, a signal artifact monitor (sam) episode was stored with a vector switch.Boston scientific technical services (ts) also noted that noise was present on the ra as well as the right ventricular (rv) lead and left ventricular (lv) lead.Additionally, atrial signals were oversensed by the rv.According to the field presentative, an ra lead revision has been scheduled in the upcoming weeks.Further information was received that a revision procedure was performed and the ra lead was surgically abandoned and replaced.No adverse patient effects were reported.At this time, this device system remains in service.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited low out of range pace impedance measurements on the right atrial (ra) lead.As a result, a signal artifact monitor (sam) episode was stored with a vector switch.Boston scientific technical services (ts) also noted that noise was present on the ra as well as the right ventricular (rv) lead and left ventricular (lv) lead.Additionally, atrial signals were oversensed by the rv.According to the field presentative, an ra lead revision has been scheduled in the upcoming weeks.Further information was received that a revision procedure was performed and the ra lead was surgically abandoned and replaced.Additional information was received that the battery of this device was suspected to be depleting prematurely.Ts calculated the battery longevity on current programmed settings and discussed it should be 8.5 years and the device is indicating 1.5 years to explant.Additionally, the power consumption of the device was found to be excessively high.A request was made to have data from this device analyzed.Data analysis confirmed the device to be malfunctioning in a manner consistent with a failure of the ra pacing channel.Multiple "leadimpcalnoise" daily ra measures, low ra measures and extreme power consumption were observed.Device replacement was recommended due to risk of damaging the pacing lead due to corrosion from current leakage.Upon further evaluation, the hcp suspected loss of capture (loc) in the newly implanted ra lead.Ts discussed testing it on the pacing system analyzer (psa) to determine if the issue was with the pg or if the lead had been damaged.A device changeout procedure was performed and it was confirmed the ra lead exhibited loc on this device, the psa and the new can, therefore, the physician explanted and replaced the ra lead and this device.No additional adverse patient effects were reported.It is expected to receive these products for analysis.The complaint device was not returned to boston scientific, therefore, product analysis could not be performed.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the product was performed.Review of device memory confirmed the presence of a higher-than-normal current drain condition.Electrical testing and analysis were then conducted, which isolated the high current to an anomaly in an oxide layer within a custom integrated circuit component.This anomaly caused a high current drain, which over time resulted in the reported clinical observations.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited low out of range pace impedance measurements on the right atrial (ra) lead.As a result, a signal artifact monitor (sam) episode was stored with a vector switch.Boston scientific technical services (ts) also noted that noise was present on the ra as well as the right ventricular (rv) lead and left ventricular (lv) lead.Additionally, atrial signals were oversensed by the rv.According to the field presentative, an ra lead revision has been scheduled in the upcoming weeks.Further information was received that a revision procedure was performed and the ra lead was surgically abandoned and replaced.Additional information was received that the battery of this device was suspected to be depleting prematurely.Ts calculated the battery longevity on current programmed settings and discussed it should be 8.5 years and the device is indicating 1.5 years to explant.Additionally, the power consumption of the device was found to be excessively high.A request was made to have data from this device analyzed.Data analysis confirmed the device to be malfunctioning in a manner consistent with a failure of the ra pacing channel.Multiple "leadimpcalnoise" daily ra measures, low ra measures and extreme power consumption were observed.Device replacement was recommended due to risk of damaging the pacing lead due to corrosion from current leakage.Upon further evaluation, the hcp suspected loss of capture (loc) in the newly implanted ra lead.Ts discussed testing it on the pacing system analyzer (psa) to determine if the issue was with the pg or if the lead had been damaged.A device changeout procedure was performed and it was confirmed the ra lead exhibited loc on this device, the psa and the new can, therefore, the physician explanted and replaced the ra lead and this device.No additional adverse patient effects were reported.This product has been received for analysis.

• 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: 18678157
• MDR Text Key: 335220012
• Report Number: 2124215-2024-07592
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589140
• UDI-Public: 00802526589140
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2024
• Device Model Number: G126
• Device Catalogue Number: G126
• Device Lot Number: 106419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male