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

Model Number G141

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Delayed Charge Time (2586); Defective Device (2588); Battery Problem (2885)

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

Event Date 01/18/2023

Event Type  Injury  

Event Description

It was reported that there was an alert for battery capacity depleted for this cardiac resynchronization therapy defibrillator (crt-d).Device data was preserved and submitted for boston scientific engineering review.Engineering analysis showed that this crt-d experienced 2 consecutive high voltage short lead events followed by end of life (eol).Technical services (ts) recommended replacement of both this crt-d and right ventricular (rv) lead.Then, this patient experienced cardiac arrest and was hospitalized.Upon interrogation a code 1007 was observed, which is indicative of capacitor charge time has exceeded the limit.The charge times were found to be greater than 45 seconds.This patient underwent a surgical procedure in which this crt-d was explanted, and the rv lead remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

This device is expected to be returned and analyzed.A supplemental report will be issued at the time of completion.

Event Description

It was reported that there was an alert for battery capacity depleted for this cardiac resynchronization therapy defibrillator (crt-d).Device data was preserved and submitted for boston scientific engineering review.Engineering analysis showed that this crt-d experienced 2 consecutive high voltage short lead events followed by end of life (eol).Technical services (ts) recommended replacement of both this crt-d and right ventricular (rv) lead.Then, this patient experienced cardiac arrest and was hospitalized.Upon interrogation a code 1007 was observed, which is indicative of capacitor charge time has exceeded the limit.The charge times were found to be greater than 45 seconds.This patient underwent a surgical procedure in which this crt-d was explanted, and the rv lead remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection of the device identified an arc mark on the device case.Review of device memory found a shorted lead error code 1004 had been recorded.Memory also showed that after three shocks had been attempted and resulted in abnormal shock impedance measurements, the device battery status moved to end of life (eol) due to long charge times.An x-ray of the device revealed that the internal high voltage fuse was damaged (i.E., no longer intact).The damage to the fuse most likely occurred during delivery of the shock that resulted in the shorted lead error.The damage to the high voltage fuse prevented any subsequent charging of the high voltage capacitors and delivery of shock therapy.As a result, the third high voltage charge attempt caused the device to declare eol because it could not successfully complete charging within 30 seconds, despite the fact that significant battery voltage and capacity remained.

• Brand Name: INOGEN CRT-D
• 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: 16278990
• MDR Text Key: 308567910
• Report Number: 2124215-2023-04131
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: 00802526534553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2020
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 126834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2018
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male