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

Model Number	0286
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Codes	Arrhythmia (1721); Asystole (4442)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the health care professional (hcp) requested review of 2 episodes for this patient with this implantable cardioverter defibrillator (icd).First, the right ventricular (rv) lead faced pacing inhibition for more than two seconds due to noise oversensing, and the right atrial (ra) lead also detected noise and oversensing.Second, a non-sustained ventricular tachycardia was triggered by a premature ventricular contraction (pvc) that fell into the blanking period, leading to an extra ventricular pacing and subsequently initiating an arrhythmia.Technical services (ts) recommended reprogramming options and a possible lead revision may be required.No additional adverse effects on the patient were reported, and the system remains in service.

• Brand Name: ENDOTAK RELIANCE G
• 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: 20846783
• Report Number: 2124215-2024-76659
• Device Sequence Number: 8100850
• Product Code: NVY
• UDI-Device Identifier: 00802526431418
• UDI-Public: 00802526431418
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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: 10/09/2016
• Device Model Number: 0286
• Device Catalogue Number: 0286
• Device Lot Number: 310731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/04/2024
• Date Device Manufactured: 10/09/2014
• 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: 77 YR
• Patient Sex: Male