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

Model Number F162

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

Patient Problems Septic Shock (2068); No Consequences Or Impact To Patient (2199)

Event Date 04/06/2019

Event Type  Injury  

Event Description

It was reported that a patient was hospitalized for sepsis infection in which the device was interrogated and presented error code 1003.The patient is currently being treated for infection however due to the patient's condition explant and exchange procedure has not been performed.There were no additional adverse effects reported.Based on the information provided the device is currently still explanted.Should further information be provided an updated report will be provided.

Manufacturer Narrative

This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Review of the device memory indicated that a low voltage alert, code 1003, was recorded.The battery voltage was lower than expected, but still supported full device function.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high current condition associated with a compromised low voltage capacitor connected to the device's battery.Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times.Malfunction of these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal.The degradation and resultant product performance issue with this low-voltage capacitor component is caused by the presence of excess hydrogen gas within the pulse generator case.Investigation determined that the hydrogen was generated by a different component the high-voltage capacitors.In 2014, a new high-voltage capacitor design was implemented in the cognis, teligen, incepta, energen, punctua, and subsequent product families.This new design eliminated the galvanic effect that can generate excess hydrogen in the same manner.This device was manufactured prior to implementation of this new high-voltage capacitor design.

Event Description

It was reported that a patient was hospitalized for sepsis infection in which the device was interrogated and presented error code 1003.The patient is currently being treated for infection however due to the patient's condition explant and exchange procedure was delayed.This device has since been explanted and is no longer in service.There were no additional adverse effects reported.This device has since been received for analysis and the investigative results are as enclosed.

• 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
• MDR Report Key: 8809097
• MDR Text Key: 151644233
• Report Number: 2124215-2019-13943
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/21/2014
• Device Model Number: F162
• Device Catalogue Number: F162
• Device Lot Number: 101384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 09/20/2019
• Removal/Correction Number: TR12009
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening