MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE LEAD

Model Number 3501

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Failure to Select Signal (1582); Device Sensing Problem (2917)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 12/14/2018

Event Type  Injury  

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 smart pass was off, and this caller requested assistance to program it back on.A boston scientific technical services consultant provided directions and smart pass was re-enabled.Appropriate sensing was confirmed.Further discussion revealed the patient has received some inappropriate shocks due to noise.The consultant recommended further troubleshooting to determine if noise is reproducible and if so, review other sense vectors to see if there is a better option for this patient.No adverse patient effects were reported.

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.The 3191 code was utilized due to the surgery that occurred.

Event Description

It was reported that this system was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9667940
• MDR Text Key: 177762202
• Report Number: 2124215-2020-02594
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: 00802526599200
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/08/2020
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 113432
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR