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

Model Number G179

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

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

Event Date 02/04/2024

Event Type  malfunction  

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.

Event Description

It was reported that the estimated battery longevity for the cardiac resynchronization therapy defibrillator (crt-d) decreased from two years remaining to elective replacement indicator (eri) within three months' time frame.Technical services (ts) was contacted to review the data.Upon review, ts determined the power consumption of the device has been stable and the voltage was decreasing as expected.Engineering analysis determined the device was depleting normally.A deeper analysis of the data was performed due to the decrease in longevity within the short time frame.Review of that data determined the rate of depletion is normal, however the charge time began to increase earlier than expected.Eri was set due to two charges in excess of 15 seconds.The charge time increase was unanticipated and eri was set early than expected.Engineering confirmed that although eri declaration was shorter than expected, the longevity of the crt-d is still within the expected time frame as the device lasted 8.9 years from implant to eri.Ts discussed that normal change out time frame post eri declaration is acceptable.At this time the crt-d remains in service and no adverse 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: 18779563
• MDR Text Key: 336235546
• Report Number: 2124215-2024-11350
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/04/2016
• Device Model Number: G179
• Device Catalogue Number: G179
• Device Lot Number: 103494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR