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

Model Number A219

Device Problem Interrogation Problem (4017)

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

Event Date 02/28/2023

Event Type  Injury  

Event Description

It was reported that during a routine device follow-up, the device was not able to be interrogated.Telemetry could not be established.A different wand and different programmers (model 3300 and 3200) were used but interrogation was still not successful.The patient was brought to a different room to minimize any potential interference but interrogation was still not possible.Technical services was contacted and a magnet reset was tried.It took several attempts, but finally the s-icd was able to be interrogated.No device issues were observed.Technical services reviewed programmer log files for this device and found a history of communication challenges over time.The data in latitude confirmed multiple instances where the scan/detect had to be retried.Engineering analysis of the available data confirmed the magnet reset was successful and the patient's remote interrogation from home in latitude was also successful.The data confirmed no evidence of premature battery depletion and normal device operation.Technical services recommended continuing with normal, routine follow ups.No adverse patient effects were reported.The device remains implanted and in service.Two weeks later, the patient's remote interrogation was unsuccessful and the patient presented to the clinic for a programmer interrogation.The same situation occurred as last time, where difficulty establishing telemetry and interrogating the device were observed.After about an hour of troubleshooting and trying, the device was able to be interrogated.Device and programmer data was to be submitted to technical services for review.However, at this time the physician is planning to replace the device in may due to the interrogation difficulties.Technical services agreed the inconsistent behavior merits consideration for replacement.

Manufacturer Narrative

This report will be updated when additional information is received.

Event Description

It was reported that during a routine device follow-up, the device was not able to be interrogated.Telemetry could not be established.A different wand and different programmers (model 3300 and 3200) were used but interrogation was still not successful.The patient was brought to a different room to minimize any potential interference but interrogation was still not possible.Technical services was contacted and a magnet reset was tried.It took several attempts, but finally the s-icd was able to be interrogated.No device issues were observed.Technical services reviewed programmer log files for this device and found a history of communication challenges over time.The data in latitude confirmed multiple instances where the scan/detect had to be retried.Engineering analysis of the available data confirmed the magnet reset was successful and the patient's remote interrogation from home in latitude was also successful.The data confirmed no evidence of premature battery depletion and normal device operation.Technical services recommended continuing with normal, routine follow ups.No adverse patient effects were reported.The device remains implanted and in service.Two weeks later, the patient's remote interrogation was unsuccessful and the patient presented to the clinic for a programmer interrogation.The same situation occurred as last time, where difficulty establishing telemetry and interrogating the device were observed.After about an hour of troubleshooting and trying, the device was able to be interrogated.Device and programmer data was to be submitted to technical services for review.However, at this time the physician is planning to replace the device in may due to the interrogation difficulties.Technical services agreed the inconsistent behavior merits consideration for replacement.The device was explanted and replaced as planned.No additional adverse patient effects were reported.The explanted device was expected to be returned for analysis.

Manufacturer Narrative

This product has not yet been received at boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited telemetry difficulty issues with no conclusive evidence of a malfunction; please refer to the description for more information regarding the specific circumstances of this event.The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Manufacturer Narrative

This product has not yet been received at boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited telemetry difficulty issues with no conclusive evidence of a malfunction; please refer to the description for more information regarding the specific circumstances of this event.The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Telemetry issues were encountered in the laboratory setting.The patient log showed a pattern of writes and resets indicative of behavior consistent with a shortened telemetry wake-up pulse behavior ('radiofrequency/rf wake-up period') associated with the crystal oscillator within the rf circuit.This resulted in the intermittent interrogation difficulties experienced in the field.It should be noted that tachycardia therapy remained available to the patient while the device was implanted.Boston scientific's investigation determined that the crystal oscillator within the rf circuit can be slow to start up if there is a high impedance within the crystal.This component behavior can be intermittent and can be affected by temperature.When the crystal oscillator is slow to start up, it directly shortens the rf wake-up period, and can result in an inability to successfully interrogate the device.

Event Description

It was reported that during a routine device follow-up, the device was not able to be interrogated.Telemetry could not be established.A different wand and different programmers (model 3300 and 3200) were used but interrogation was still not successful.The patient was brought to a different room to minimize any potential interference but interrogation was still not possible.Technical services was contacted and a magnet reset was tried.It took several attempts, but finally the s-icd was able to be interrogated.No device issues were observed.Technical services reviewed programmer log files for this device and found a history of communication challenges over time.The data in latitude confirmed multiple instances where the scan/detect had to be retried.Engineering analysis of the available data confirmed the magnet reset was successful and the patient's remote interrogation from home in latitude was also successful.The data confirmed no evidence of premature battery depletion and normal device operation.Technical services recommended continuing with normal, routine follow ups.No adverse patient effects were reported.The device remains implanted and in service.Two weeks later, the patient's remote interrogation was unsuccessful and the patient presented to the clinic for a programmer interrogation.The same situation occurred as last time, where difficulty establishing telemetry and interrogating the device were observed.After about an hour of troubleshooting and trying, the device was able to be interrogated.Device and programmer data was to be submitted to technical services for review.However, at this time the physician is planning to replace the device in may due to the interrogation difficulties.Technical services agreed the inconsistent behavior merits consideration for replacement.The device was explanted and replaced as planned.No additional adverse patient effects were reported.The explanted device was expected to be returned for analysis.

• Brand Name: EMBLEM MRI 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: 16811866
• MDR Text Key: 313986736
• Report Number: 2124215-2023-19948
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P110042/S058
• 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,Followup,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/22/2019
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 219086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male