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

Model Number G179

Device Problems High impedance (1291); Failure to Read Input Signal (1581); Failure to Select Signal (1582)

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

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device and lead remain implanted and in service.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and associated right ventricular (rv) lead exhibited high, out-of-range (oor) shock impedance measurements.An alert was generated in the remote monitoring system.No electrograms showed noise on the rv lead.Technical services reviewed the available data and confirmed one oor measurement had occurred in (b)(6) 2019, with normal measurements of 85-95 ohms observed until this new spike of 131 ohms.Technical services recommended bringing the patient into the clinic for troubleshooting, including provocative maneuvers to attempt to create noise on the lead.If no noise could be produced, they could continue monitoring the shock impedance in the remote monitoring system, and could adjust the shock impedance limit in the device to 150 ohms to avoid new alerts for this issue.No adverse patient effects were reported.

Manufacturer Narrative

The device and lead remain implanted and in service.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and associated right ventricular (rv) lead exhibited high, out-of-range (oor) shock impedance measurements.An alert was generated in the remote monitoring system.No electrograms showed noise on the rv lead.Technical services reviewed the available data and confirmed one oor measurement had occurred in february 2019, with normal measurements of 85-95 ohms observed until this new spike of 131 ohms.Technical services recommended bringing the patient into the clinic for troubleshooting, including provocative maneuvers to attempt to create noise on the lead.If no noise could be produced, they could continue monitoring the shock impedance in the remote monitoring system, and could adjust the shock impedance limit in the device to 150 ohms to avoid new alerts for this issue.No adverse patient effects were reported.Additional information was received.In the patient's remote interrogation in june 2024 a new alert was recorded for a high, out-of-range shock impedance measurement of 154 ohms.A request was made for technical services to review the device data and provide a recommendation.

• 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: 9208252
• MDR Text Key: 165609174
• Report Number: 2124215-2019-21584
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2024

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: 01/18/2019
• Device Model Number: G179
• Device Catalogue Number: G179
• Device Lot Number: 163664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 06/03/2024
• Supplement Dates FDA Received: 06/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR