MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	0283
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device check of this implantable cardioverter defibrillator (icd) system revealed a gradual increase in right ventricular (rv) lead pace impedance measurements over the last five years from 1,300 ohms to 2,286 ohms and signal artifact monitoring (sam) disabled the respiratory rate trend (rrt) feature.Additionally, threshold measurements had increased to 3.1v@ms and pacing outputs were increased.No oversensing was noted, and the patient is not pacer dependent.This icd system remains in service and will continue to be monitored.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.Correction to h6 / device codes: device coding updated to include high capture thresholds, to reflect event description (b5).
Event or Problem Description
It was reported that a device check of this implantable cardioverter defibrillator (icd) system revealed a gradual increase in right ventricular (rv) lead pace impedance measurements over the last five years from 1,300 ohms to 2,286 ohms and signal artifact monitoring (sam) disabled the respiratory rate trend (rrt) feature.Additionally, threshold measurements had increased to 3.1v@ms and pacing outputs were increased.No oversensing was noted, and the patient is not pacer dependent.This icd system remains in service and will continue to be monitored.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17514595
• Report Number: 2124215-2023-43082
• Device Sequence Number: 12146609
• Product Code: NVY
• UDI-Device Identifier: 00802526431388
• UDI-Public: 00802526431388
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/30/2019
• Device Model Number: 0283
• Device Catalogue Number: 0283
• Device Lot Number: 419837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male