MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D142

Device Problems High impedance (1291); Pacing Problem (1439); Failure to Sense (1559); Low impedance (2285)

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

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.Please note: patient code 3191 is being used to capture the prolonged procedure required during the attempted implant of this device.

Event Description

It was reported that, at time of implant of this implantable cardioverter defibrillator (icd), there was no pacing, no output, and both low and high out of range pacing impedances seen when right ventricular (rv) leads were inserted into the device header (two leads were attempted).Subsequently, a different icd was implanted in its place.No adverse patient effects were reported.

Event Description

It was reported that, at time of implant of this implantable cardioverter defibrillator (icd), there was no pacing, no output, and both low and high out of range pacing impedances seen when right ventricular (rv) leads were inserted into the device header (two leads were attempted).Subsequently, a different icd was implanted in its place.No adverse patient effects were reported.This icd was returned and analysis was completed.This report is updated with the product investigation results.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.Please note: patient code 3191 is being used to capture the prolonged procedure required during the attempted implant of this device.Update: upon receipt at our post market quality assurance laboratory, this icd was thoroughly inspected and analyzed.Visual inspection noted the right ventricular ring (rvr) electrode ring was damaged and distorted.No other anomalies were noted.Therefore, the reported clinical observations (no pacing, no output, and both low and high out of range pacing impedances at time of initial device implant) were confirmed: laboratory testing concluded a df4 lead could not be fully inserted into the rv lead barrel due to rvr electrode ring damage.However, investigation was unable to determine the cause of the rvr electrode ring damage.

• Brand Name: INOGEN EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10226569
• MDR Text Key: 197857758
• Report Number: 2124215-2020-10948
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534249
• UDI-Public: 00802526534249
• Combination Product (y/n): N
• PMA/PMN Number: P960040/S306
• 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: 07/05/2021

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: Health Professional
• Device Expiration Date: 12/06/2021
• Device Model Number: D142
• Device Catalogue Number: D142
• Device Lot Number: 575633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 07/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1