MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COGNIS; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number N108

Device Problem Pacing Problem (1439)

Patient Problem Injury (2348)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that the patient implanted with this implantable cardioverter defibrillator (icd) underwent an ablation procedure.It was reported that for the procedure, the device was programmed to voo 40 electrocautery mode.The patient was completely pacemaker dependent and during the ablation asystole was observed.The physician believed the device malfunctioned, causing the pacing to be inhibited.Technical services reviewed the available device data and discussed the defib detect circuit, a protective mechanism designed to prevent external energy/current from being delivered to an unintended location in the heart or into the device to avoid damage to the device circuitry.The defib detect circuit causes the device to truncate any pacing that is occurring at the moment and for 160 milliseconds, until the excessive energy ends.Available information indicated the patient remained hospitalized following the ablation procedure, due to the inhibited pacing.However, the field representative later confirmed that the patient's hospitalization had been a planned part of the ablation procedure and that there were only brief periods of asystole during the procedure.No adverse patient effects occurred and the device remains implanted and in service.

• Brand Name: COGNIS
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (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: 9623763
• MDR Text Key: 176237259
• Report Number: 2124215-2019-28546
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2011
• Device Model Number: N108
• Device Catalogue Number: N108
• Device Lot Number: 666721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR