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

Model Number 0283

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Impedance Problem (2950)

Patient Problem Asystole (4442)

Event Date 10/23/2023

Event Type  malfunction  

Event Description

It was reported that this right ventricular (rv) lead over-sensed noise resulting in pacing inhibition of greater than two seconds.It was noted that the patient is pacemaker dependent and in a wheelchair.The physician performed provocative maneuvers and noise oversensing was never reproduced.Oversensing of atrial activity was reproduced once during threshold testing.The physician decided to increase the rv sensitivity to 0.8 mv and adjust rv and left ventricular (lv) lead blanking during atrial pacing.Rv pacing impedance was slightly decreased from 380 ohm to 340 ohm.All other parameters were in normal range.Due to the clinical condition of the patient, the physician will continue latitude monitoring.No additional adverse patient effects were reported.This product remains in service.

Manufacturer Narrative

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

• Brand Name: ENDOTAK RELIANCE SG
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 18005807
• MDR Text Key: 326524163
• Report Number: 2124215-2023-59435
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2023

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: 02/12/2012
• Device Model Number: 0283
• Device Catalogue Number: 0283
• Device Lot Number: 010396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2010
• 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