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

Model Number E161

Device Problems High impedance (1291); Noise, Audible (3273)

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

Event Date 12/01/2022

Event Type  malfunction  

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) heard beeping from the device.Upon analysis of device data, it was found that there was an out-of-range shock lead impedance (sli) measurement of 130 ohms.Technical services (ts) analyzed device data and provided troubleshooting.Reprogramming was performed.The sli returned to within normal limits.No adverse patient effects were reported.Currently, this icd 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 there was no conclusive evidence that the observed out-of-range impedance measurements were due to a malfunction or an inadequate lead-to-device connection.However, intermittent, out-of-range shock lead impedance measurements with no conclusive evidence of a malfunction or an inadequate lead-to-device connection are likely the result of the low-energy test signal utilized for daily automatic or in-clinic commanded shock lead impedance testing.A software update was released in 2015 to further improve consistency of the impedance test results and provide the clinician with additional diagnostic tools, including programmable shock lead impedance alert limits.

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) heard beeping from the device.Upon analysis of device data, it was found that there was an out-of-range shock lead impedance (sli) measurement of 130 ohms.Technical services (ts) analyzed device data and provided troubleshooting.Reprogramming was performed.The sli returned to within normal limits.No adverse patient effects were reported.Currently, this icd remains in service.

• 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: 16060667
• MDR Text Key: 308016438
• Report Number: 2124215-2022-55295
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480768
• UDI-Public: 00802526480768
• 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,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/21/2013
• Device Model Number: E161
• Device Catalogue Number: E161
• Device Lot Number: 100584
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2012
• 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: 57 YR
• Patient Sex: Male