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); Device Displays Incorrect Message (2591)

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

Event Date 03/17/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed no low voltage fault was declared but device was depleting in a manner consistent with the low voltage capacitors advisory.Moreover, the device hardware was not detecting the loss of battery energy.Hence, the battery status indicators were not reflecting the depletion condition and were inaccurate.This should not longer be relied upon to determined the depletion status of the device.Further, the device was malfunctioning and should be replaced.To date, no intervention performed and device remains in service.No adverse patient effects were reported.

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed no low voltage fault was declared but device was depleting in a manner consistent with the low voltage capacitors advisory.Moreover, the device hardware was not detecting the loss of battery energy.Hence, the battery status indicators were not reflecting the depletion condition and were inaccurate.This should not longer be relied upon to determined the depletion status of the device.Additional information obtained from the field indicated that this device was replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14291198
• MDR Text Key: 291223770
• Report Number: 2124215-2022-14052
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/11/2017
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 110126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 92 YR
• Patient Sex: Male