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

Model Number E162

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Battery Problem (2885)

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

Event Date 09/23/2018

Event Type  malfunction  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) oversensed noise on the right ventricular (rv) lead.The patient is not pacing dependent therefore, no pacing inhibition occurred.Technical services (ts) recommended troubleshooting options and continuing to monitor.This icd and rv lead remain in service.No adverse patient effects were reported.Additional information was received and it was noted that the battery gas gauge went from five months remaining to elective replacement indicator (eri).Technical services (ts) discussed it was likely related to the monthly capacitor reform.It was noted that noise was continued to be oversensed on the rv lead.This icd and rv lead remain 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: 19060210
• MDR Text Key: 339879901
• Report Number: 2124215-2024-21144
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480775
• UDI-Public: 00802526480775
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/20/2014
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 103149
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2012
• 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: 63 YR
• Patient Sex: Male