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

Model Number G179

Device Problems Battery Problem (2885); Data Problem (3196)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited longevity changes.The remaining battery was at 7.5 years in february and dropped to 6.5 years in a 3 months time period.Additionally, data issues were also noted.It was unclear to the health care professional (hcp) if the lead trends data and threshold impedance signals stopped at any time.Boston scientific technical services (ts) was consulted and discussed it was possible the device had a reset if all trend data was missing.The hcp stated that data will be sent to be able to perform analysis, however, this was not concreted.No adverse patient effects were reported.At this time, this device remains in service.

• Brand Name: AUTOGEN
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 17086905
• MDR Text Key: 317256782
• Report Number: 2124215-2023-29433
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2018
• Device Model Number: G179
• Device Catalogue Number: G179
• Device Lot Number: 158246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1