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

Model Number G141

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

Despite multiple attempts, no additional information was available.Based on the available information, this device remains in-service.This investigation will be updated should further information be provided.

Event Description

It was reported that this patient advocate contacted boston scientific latitude support on (b)(6) 2019.The patient advocate reported that the patient monitoring system displayed a red doctor icon.The boston scientific consultant was informed that the patient was not in close proximity to the latitude communicator.The boston scientific consultant recommended that the physician should be notified and to contact boston scientific once the patient is near the communicator to report any codes that may be displayed.

Manufacturer Narrative

Despite multiple attempts, no additional information was available.Based on the available information, this device remains in-service.This investigation will be updated should further information be provided.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that this patient advocate contacted boston scientific latitude support on 10/30/2019.The patient advocate reported that the patient monitoring system displayed a red doctor icon.The boston scientific consultant was informed that the patient was not in close proximity to the latitude communicator.The boston scientific consultant recommended that the physician should be notified and to contact boston scientific once the patient is near the communicator to report any codes that may be displayed.Latitude data showed large spike in impedance.

• Brand Name: INOGEN CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• MDR Report Key: 9667072
• MDR Text Key: 177678401
• Report Number: 2124215-2019-29071
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: 00802526534553
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2017
• Device Model Number: G141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2020
• Patient Sequence Number: 1
• Patient Age: 64 YR