MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number A209

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

This device is not available for return at this time as it is still in service.No further information concerning this report is currently available.This investigation will be updated should further information be provided.

Event Description

It was reported that this device exhibited beeping tones and upon interrogation displayed battery depletion (bd) and warm boots (wb) codes.Device analysis indicated that the patient may be unprotected and it was recommended to replace the device.The device is currently still in service.No adverse patient effects were reported.

Manufacturer Narrative

This device is not available for return at this time.No further information concerning this report is currently available.This investigation will be updated should further information be provided.

Event Description

This supplemental report is being filled to include device explant information.

Event Description

This supplemental report is being filled to include device analysis information.

Manufacturer Narrative

This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.The device elicited beeping tones during magnet application; however telemetry could not be established.Evaluation of telemetry was performed by monitoring radiofrequency wake-up periods while the device was subjected to varying temperatures.This test indicated that the device measured at less than the operational threshold.This device behavior is consistent with a shortened telemetry wake-up pulse behavior associated with a telemetry component (oscillating crystal) within the rf circuit.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9548266
• MDR Text Key: 173785321
• Report Number: 2124215-2019-24918
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: 00802526544101
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2017
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 107827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 12/18/2019; 01/31/2020
• Supplement Dates FDA Received: 01/07/2020; 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 38 YR