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

Model Number D044

Device Problem Interrogation Problem (4017)

Patient Problem Shock (2072)

Event Date 09/09/2022

Event Type  Injury  

Manufacturer Narrative

This product has not been returned.As such, physical analysis has not been conducted in our laboratory.This investigation will be updated should further information be provided.

Event Description

It was reported that this patient received therapy from the implantable cardioverter defibrillator (icd) device, was brought into the hospital and device could not be interrogated.The patient admitted there where advised by the physician previously, that the device had reached end of life (eol), but has not been back to see the physician in awhile.The device was explanted, and a new device implanted.Besides surgical intervention, no adverse patient effects were reported.The device is expected to be returned for analysis.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected the device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that this patient received therapy from the implantable cardioverter defibrillator (icd) device, was brought into the hospital and device could not be interrogated.The patient admitted there where advised by the physician previously, that the device had reached end of life (eol), but has not been back to see the physician in awhile.The device was explanted, and a new device implanted.Besides surgical intervention, no adverse patient effects were reported.The device was returned, and product analysis completed.

• Brand Name: AUTOGEN
• 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: 15420527
• MDR Text Key: 299900937
• Report Number: 2124215-2022-36009
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2016
• Device Model Number: D044
• Device Catalogue Number: D044
• Device Lot Number: 103685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization