MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOGEN; CARDIAC DEFIBRILLATOR

Model Number G173

Device Problem High impedance (1291)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited out of range pacing impedance measurements in both the right atrial (ra) and right ventricular (rv) leads.The rv lead is a non-boston scientific device.The patients is in permanent atrial fibrillation (af).Boston scientific technical services (ts) reviewed the stored data and recommended actively monitoring the patient.The system remains in service.No adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.However, the associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited out of range (oor) pacing impedance measurements in both the right atrial (ra) and right ventricular (rv) leads.Both leads are non-boston scientific devices.The patient is in permanent atrial fibrillation (af).Boston scientific technical services (ts) reviewed the stored data and recommended actively monitoring the patient.The system remains in service.No adverse patient effects were reported.Additional information stated the patient is under active remote monitoring.No in-person checks have been performed so far.However, the clinic programmed alerts for non-physiological rv noise and rv oor pacing impedance.

• Brand Name: AUTOGEN
• Type of Device: CARDIAC DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11212085
• MDR Text Key: 228162919
• Report Number: 2124215-2021-01428
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/11/2018
• Device Model Number: G173
• Device Catalogue Number: G173
• Device Lot Number: 119381
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1