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

Model Number E163

Device Problems Signal Artifact/Noise (1036); Pacing Problem (1439); Inaccurate Synchronization (1609); Under-Sensing (1661)

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

Event Date 11/29/2022

Event Type  malfunction  

Event Description

It was reported that, this implantable cardioverter defibrillator (icd) system undersensed a right ventricular (rv) signal on the rv lead, leading into overpacing.Subsequently, pacemaker mediated tachycardia (pmt) was triggered and the rhythm was accelerated.Technical services (ts) recommended to reprogram the sensitivity, changing v blank after a pacing to smart from nominal 65 ms.Additionally, noisy signals were noted on the rv and right atrial (ra) channel.Ts discussed the signal could have been a short episode of external emi causing this noise.This icd remains in service.No adverse patient effects were reported.

• Brand Name: INCEPTA ICD
• 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: 15953505
• MDR Text Key: 306072305
• Report Number: 2124215-2022-51843
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480782
• UDI-Public: 00802526480782
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/24/2016
• Device Model Number: E163
• Device Catalogue Number: E163
• Device Lot Number: 109700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2014
• 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 Age: 52 YR
• Patient Sex: Male