MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA ICD; IMPLANTABLE DEVICE

Model Number E162

Device Problem Premature Discharge of Battery (1057)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Device replacement was recommended but device remains in service.No adverse patient effects were reported.

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Device replacement was recommended.Device was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was analyzed and a review of the device memory confirmed 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 battery.Low voltage capacitors are used in the high voltage charging operation in order to facilitate fast charge times.The behavior of these capacitors resulted in a high current drain, which was depleting the device battery faster than normal.This particular device was not included in the advisory population.

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Device replacement was recommended.Device was explanted.No additional adverse patient effects were reported.

• Brand Name: INCEPTA ICD
• Type of Device: IMPLANTABLE DEVICE
• 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: 11355385
• MDR Text Key: 232874780
• Report Number: 2124215-2021-02825
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2015
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 107865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male