MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION THE Q-TRAK SUBCUTANEOUS ELECTRODE; IMPLANTABLE LEAD

Model Number 3010

Device Problems Signal Artifact/Noise (1036); 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 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.

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.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection revealed insulation damage near the electrode terminal end.The insulation abrasion went through to the high voltage lumen with additional damage to the sense a lumen.This type of damage is consistent with repeated stress over time.In this case, we believe the stress was the result of lead contact with the associated device case.The reported low shock impedance measurement, failure to convert rhythm and sense, and noisy signals allegations were likely the result of the electrode damage observed by the laboratory.

• Brand Name: THE Q-TRAK SUBCUTANEOUS ELECTRODE
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14806369
• MDR Text Key: 294837814
• Report Number: 2124215-2022-22779
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110042/S000
• 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
• Report Date: 09/30/2022

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: 10/01/2016
• Device Model Number: 3010
• Device Catalogue Number: 3010
• Device Lot Number: A115438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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