MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TELIGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number F111

Device Problem Inaccurate Synchronization (1609)

Patient Problem Ventricular Fibrillation (2130)

Event Date 05/26/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this device stored multiple ventricular tachycardia (vt) episodes that may have been inappropriate due to atrial fibrillation (af) with rapid ventricular response (rvr).In one episode, anti-tachycardia pacing (atp) was delivered, which induced a ventricular fibrillation (vf).The vf was successfully terminated with a 31 joule shock.A request was made for technical services to review the device data and episodes, to ensure appropriate device function.No adverse patient effects were reported.The device remains implanted and in service.Technical services reviewed the available data and episodes.The device initially inhibited the therapy as the detection enhancements indicated that rhythmid was correlated.At some point in time, an atrial beat was undersensed as it felt into cross-chamber blanking.This caused v>a to be true, and this overrules the other detection enhancements.The device then triggered atp that in turn induced a vf.The device detected it and issued a 31 j shock that successfully converted the arrhythmia.As the cross-chamber blanking is already set to smart, there is no option to shorten it even more (currently 15 ms).Other programming options would be to either increase the vt-1 cut-off zone to a value higher than what it is currently set.However, this raises the concern of not treating slow vts.Another possibility to be considered is to have v>a disabled as a detection enhancement.This would increase the likelihood of withholding therapy for this type of rhythm.

• Brand Name: TELIGEN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• 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: 15242722
• MDR Text Key: 298072816
• Report Number: 2124215-2022-31070
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2012
• Device Model Number: F111
• Device Catalogue Number: F111
• Device Lot Number: 103948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 78 YR