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

Model Number G140

Device Problems High impedance (1291); Material Integrity Problem (2978)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated.

Event Description

It was reported during a revision procedure that this cardiac resynchronization therapy defibrillator (crt-d) device exhibited high out of range pacing impedance measurements of 3,000 ohms.A different device was implanted.Testing of the right ventricular (rv) lead with the pacing system analyzer (psa) confirmed this was not a lead issue, and more than likely a header issue.No adverse patient effects were reported.The device is expected to be returned for analysis.

Event Description

It was reported during a revision procedure that this cardiac resynchronization therapy defibrillator (crt-d) device exhibited high out of range pacing impedance measurements of 3,000 ohms.A different device was implanted.Testing of the right ventricular (rv) lead with the pacing system analyzer (psa) confirming this was not a lead issue, and more than likely a header issue.No adverse patient effects were reported.The device is expected to be returned for analysis.

Manufacturer Narrative

The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the report clinical observations.

• 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
• MDR Report Key: 10681591
• MDR Text Key: 211453439
• Report Number: 2124215-2020-20716
• Device Sequence Number: 1
• Product Code: NIK
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: G140
• Device Catalogue Number: G140
• Device Lot Number: 498977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 03/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other