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

Model Number A209

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Convert Rhythm (1540); Failure to Sense (1559); Low impedance (2285)

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

Event Date 05/24/2022

Event Type  Injury  

Event Description

It was reported that at a routine subcutaneous implantable defibrillator (s-icd) device replacement procedure for normal battery depletion, this device was implanted and with the automatic screening tool (ast), was programmed to the same sensing vector as the former device.However, when the physician performed an induction test, the shock was unable to convert the induced ventricular fibrillation (vf).Additionally, the real time internal device electrocardiogram (egm) displayed a flat line showing a lack of sensing.This was followed by high amplitude non-cardiac noisy signals.Because the patient was still in vf, the patient was externally shocked to convert their arrhythmia.The testing result for the induced shock revealed an impedance measurement of 1 ohm.The device was able to interrogated via telemetry and the physician noted an unspecified red alert message.Because there were no additional replacement devices available, the physician turned off the shock therapy and the patient was hospitalized.A surgical replacement procedure is anticipated, but has not yet been performed.At this time, this s-icd device remains implanted and no additional adverse effects were reported.

Event Description

It was reported that at a routine subcutaneous implantable defibrillator (s-icd) device replacement procedure for normal battery depletion, this device was implanted and with the automatic screening tool (ast), was programmed to the same sensing vector as the former device.However, when the physician performed an induction test, the shock was unable to convert the induced ventricular fibrillation (vf).Additionally, the real time internal device electrocardiogram (egm) displayed a flat line showing a lack of sensing.This was followed by high amplitude non-cardiac noisy signals.Because the patient was still in vf, the patient was externally shocked to convert their arrhythmia.The testing result for the induced shock revealed an impedance measurement of 1 ohm.The device was able to interrogated via telemetry and the physician noted an unspecified red alert message.Because there were no additional replacement devices available, the physician turned off the shock therapy and the patient was hospitalized.A few days later, the physician surgically explanted and replaced the entire s-icd system to resolve the event.No additional adverse effects were reported.The system is expected to be returned for analysis, but has not yet been received.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a visual inspection of the device noted an arc mark on the titanium case.Arcing damage like that seen with this device is consistent with an attempt to deliver therapy through a shorted lead system, which may cause internal damage to the circuitry.Based on inspection and analysis of this device, evidence indicates the device was damaged after delivering a shock through a shorted defibrillation electrode.

Event Description

It was reported that at a routine subcutaneous implantable defibrillator (s-icd) device replacement procedure for normal battery depletion, this device was implanted and with the automatic screening tool (ast), was programmed to the same sensing vector as the former device.However, when the physician performed an induction test, the shock was unable to convert the induced ventricular fibrillation (vf).Additionally, the real time internal device electrocardiogram (egm) displayed a flat line showing a lack of sensing.This was followed by high amplitude non-cardiac noisy signals.Because the patient was still in vf, the patient was externally shocked to convert their arrhythmia.The testing result for the induced shock revealed an impedance measurement of 1 ohm.The device was able to interrogated via telemetry and the physician noted an unspecified red alert message.Because there were no additional replacement devices available, the physician turned off the shock therapy and the patient was hospitalized.A few days later, the physician surgically explanted and replaced the entire s-icd system to resolve the event.No additional adverse effects were reported.The system was received for analysis.

• 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: 14640192
• MDR Text Key: 293627300
• Report Number: 2124215-2022-20383
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/29/2024
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 161603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 06/10/2022; 10/12/2022
• Supplement Dates FDA Received: 06/24/2022; 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male