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

Model Number D143

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Communication or Transmission Problem (2896); Impedance Problem (2950)

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

Event Date 03/19/2023

Event Type  malfunction  

Event Description

It was reported that there was an issue involving a missed latitude remote patient monitoring system transmission, which was resolved via a phone call with a boston scientific remote clinical specialist.During this phone call, recent out-of-range right ventricular (rv) lead impedance measurements were also noted, and in-clinic troubleshooting efforts were discussed at length.Of note, the rv lead is a non-boston scientific product.This implantable cardioverter defibrillator (icd) system remains in service, and no adverse patient effects were reported.

Manufacturer Narrative

This device remains implanted; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was an issue involving a missed latitude remote patient monitoring system transmission, which was resolved via a phone call with a boston scientific remote clinical specialist.During this phone call, recent out-of-range right ventricular (rv) lead impedance measurements were also noted, and in-clinic troubleshooting efforts were discussed at length.Of note, the rv lead is a non-boston scientific product.This implantable cardioverter defibrillator (icd) system remains in service, and no adverse patient effects were reported.Additional information received indicates that oversensing of non-cardiac signals resulting in inappropriate therapy delivery has also been observed.Troubleshooting to better understand where the lead issue is and exclude any possible pocket-related situation was once again recommended.No adverse patient effects were reported.

• 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
• 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: 16670273
• MDR Text Key: 312594631
• Report Number: 2124215-2023-15618
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534263
• UDI-Public: 00802526534263
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

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: Lay User/Patient
• Device Expiration Date: 05/01/2020
• Device Model Number: D143
• Device Catalogue Number: D143
• Device Lot Number: 212793
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2018
• 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