MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOGEN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G173

Device Problem High impedance (1291)

Patient Problems Atrial Fibrillation (1729); No Consequences Or Impact To Patient (2199)

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.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's 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.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) device, and non-boston scientific leads exhibited one episode of high, out of range pacing impedance greater than 2,000 ohms.There were no other out of range measurements, and no noise present.A technical service (t/s) consultant, reviewed the device data and suggested programming options, and lead integrity testing.It was also noted, that the analysis showed the patient to be exhibiting atrial fibrillation.T/s recommended following patient closely over a home monitor equipment.The device remains in service.No adverse patient effects were reported.

• Brand Name: AUTOGEN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• 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: 10714607
• MDR Text Key: 212475042
• Report Number: 2124215-2020-21335
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/12/2017
• Device Model Number: G173
• Device Catalogue Number: G173
• Device Lot Number: 113316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1