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); Failure to Read Input Signal (1581); Under-Sensing (1661)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that a remote alert was received from this subcutaneous implantable cardioverter defibrillator (s-icd), indicating that a battery depletion (bd) alert was declared.Additionally, the physician observed that the smartpass feature had automatically disabled.Boston scientific technical services (ts) was contacted for a data review and it was confirmed that the s-icd battery was exhibiting premature depletion.Replacement was recommended within 90 days.Additionally, it was discussed that the smartpass feature had been appropriately disabled due to under-sensed low amplitude measurements.There was no evidence of impact to therapy delivery.At this time, the s-icd remains implanted and in-service.No adverse patient effects were reported.

Manufacturer Narrative

This report is being sent to correct fields b1, b2, b5, and h1.

Event Description

It was reported that a remote alert was received from this subcutaneous implantable cardioverter defibrillator (s-icd), indicating that a battery depletion (bd) alert was declared.Additionally, the physician observed that the smartpass feature had automatically disabled.Boston scientific technical services (ts) was contacted for a data review and it was confirmed that the s-icd battery was exhibiting premature depletion.Replacement was recommended within 90 days.Additionally, it was discussed that the smartpass feature had been appropriately disabled due to under-sensed low amplitude measurements.There was no evidence of impact to therapy delivery.The physician subsequently explanted and replaced the device to resolve the event and no additional adverse patient effects were reported.This s-icd has been returned for analysis.Once the investigation is completed, this record will be updated with results.

• 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
• 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: 19009031
• MDR Text Key: 339230354
• Report Number: 2124215-2024-19231
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110042/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/22/2019
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 212546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 57 YR