MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D121

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581); Inaccurate Synchronization (1609); High Capture Threshold (3266)

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

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.

Event Description

It was reported that the clinic noted cross talk on both the right atrial (ra) and right ventricular (rv) channels on the presenting electrogram (egm) and requested further review.Review by the field representative noted that the signal was not sensed on the atrial channel due to small amplitude.The signal was sensed on the ventricular channel, however it was within blanking and not be utilized by the implantable cardioverter defibrillator (icd).It was noted there were no inappropriate therapies given and no loss of bradycardia pacing due to the oversensing.No x-ray image had been taken since change out procedure almost two years earlier.Technical services (ts) was consulted to review the information.Upon review ts noted the lead impedance measurements were within range.No other oversensing episodes were noted.Ts discussed programming options including extending the ventricular blanking after atrial pace.Ts also found a stored episode of pacemaker mediated tachycardia (pmt) from two months earlier where pmt covered retrograde conduction.Ts discussed programming options.Further review of stored episodes found high rv pacing thresholds with programmed high output.Ts discussed that this can affect battery longevity.Ts noted that high pacing thresholds along with low intrinsic amplitude may indicate that the chronic lead has experienced changes at the tip and tissue surface such as calcification.Review of an egm from one year earlier suggested possible therapy induced arrhythmia.Ts noted that the ventricular fibrillation (vf) was successfully treated with a quick convert anti-tachycardia pacing (atp).However, the onset of the vf appeared to be related to an atrial pace with ventricular sense in hysteresis and another ventricular sense in blanking that came into an atrial pace with cross chamber blanking.The next ventricular pace likely contributed to the arrhythmia onset.Ts discussed that it is per the physician discretion to keep the system as it is or to consider a new lead implant once the threshold becomes as high as capture may not be present or the r-wave amplitude decreases even more to compromise appropriate sensing of fast ventricular rates.The icd and leads remain in service and no adverse effects were reported.

• Brand Name: MOMENTUM EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 16700570
• MDR Text Key: 312867999
• Report Number: 2124215-2023-16340
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960040/S385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2023

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: 03/15/2023
• Device Model Number: D121
• Device Catalogue Number: D121
• Device Lot Number: 226447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other