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

Model Number A209

Device Problems Failure to Charge (1085); Failure to Convert Rhythm (1540); Failure to Sense (1559); Defibrillation/Stimulation Problem (1573); Low impedance (2285)

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

Event Date 04/12/2023

Event Type  Injury  

Event Description

It was reported that during a change out procedure for normal battery depletion, after the new subcutaneous implantable cardioverter defibrillator (s-icd) was implanted and the shock test was performed there was non-conversion of induced ventricular tachycardia (vt).Another charge was given and there was no signal on the electrogram (egm).An external shock was given to the patient.The shock impedance was at 10 ohms and the device was unable to charge for another shock.The physician opted to explant the existing electrode and implant a new s-icd and electrode.It was noted that the electrode had been repositioned during the procedure due to concern over future perforation.There was also concern over a shock into a shorted condition.Visual inspection of the s-icd and electrode did not reveal any findings.The attempted s-icd and chronic electrode were taken out of the patient and a new s-icd system was successfully implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.Upon receipt at our post market quality assurance laboratory, visual inspection found arc mark on can.An x-ray image revealed damage to the high voltage capacitor flex circuit.Analysis findings confirmed the field allegations and no therapy availability.The arc mark was likely caused by shock being delivered with electrode in close proximity to the case.

Event Description

It was reported that during a change out procedure for normal battery depletion, after the new subcutaneous implantable cardioverter defibrillator (s-icd) was implanted and the shock test was performed there was non-conversion of induced ventricular tachycardia (vt).Another charge was given and there was no signal on the electrogram (egm).An external shock was given to the patient.The shock impedance was at 10 ohms and the device was unable to charge for another shock.The physician opted to explant the existing electrode and implant a new s-icd and electrode.It was noted that the electrode had been repositioned during the procedure due to concern over future perforation.There was also concern over a shock into a shorted condition.Visual inspection of the s-icd and electrode did not reveal any findings.The attempted s-icd and chronic electrode were taken out of the patient and a new s-icd system was successfully implanted.No additional adverse patient effects were reported.

• 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: 16891307
• MDR Text Key: 314782862
• Report Number: 2124215-2023-22393
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 10/13/2023

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 Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 181366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization