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

Model Number A209

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959); Data Problem (3196)

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

Event Date 03/09/2023

Event Type  malfunction  

Manufacturer Narrative

Device memory analysis identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency and patient data.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.Technical services advised the patient should be seen so that the patient data could be reset, but that critical therapy remained available.

Event Description

It was reported that during a device interrogation of the subcutaneous implantable cardioverter defibrillator (s-icd) a code displayed indicating there was an issue with patient data.The programmer was restarted and the code no longer displayed.However the patient data was deleted.Technical services (ts) was consulted and discussed that the code indicated a benign memory inconsistency that does not effect normal operation or therapy delivery.Device longevity is also unaffected.Ts discussed that when this code is detected the patient data is deleted but can be restored manually.The implant data will be set when manual or automatic sensing setup is next performed and is unable to be corrected.The stored and captured s-ecg data and timestamps will not be affected.

• 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: 16725696
• MDR Text Key: 313145351
• Report Number: 2124215-2023-17142
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: 00802526544101
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/20/2020
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 238250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1