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

Model Number A219

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Data Problem (3196)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that the health care professional (hcp) called regarding a red screen during an in-office interrogation stating the device required immediate attention.Technical services walked through restoring the device and the device was able to be successfully interrogated.The hcp reported there were stored episodes to view and was able to retrieve the episodes.Ts recommended log files to be submitted for analysis.Engineering analysis found the programmer log files showed a pd error however, the error was benign.At this time, the device remains in service.No adverse patient effects were reported.

Event Description

It was reported that the health care professional (hcp) called regarding a red screen during an in-office interrogation stating the device required immediate attention.Technical services walked through restoring the device and the device was able to be successfully interrogated.The hcp reported there were stored episodes to view and was able to retrieve the episodes.Ts recommended log files to be submitted for analysis.Engineering analysis found the programmer log files showed a pd error however, the error was benign.At this time, the device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

Device memory analysis identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The cause of the memory inconsistency was not able to be determined but was likely the result of a single event upset caused by high energy particles in the environment.These particles typically arise from therapeutic ionizing radiation, naturally occurring high energy particles/cosmic rays, or radioactive decaying materials.In most cases the s-icd is able to detect and self-correct to maintain primary operation.

• Brand Name: EMBLEM MRI S-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: 18950973
• MDR Text Key: 338475707
• Report Number: 2124215-2024-17219
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2024
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 158982
• 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: 03/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female