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

Model Number 0292

Device Problems Pocket Stimulation (1463); Difficult to Remove (1528); Low impedance (2285); Adverse Event Without Identified Device or Use Problem (2993); High Capture Threshold (3266)

Patient Problems Cardiac Perforation (2513); Diminished Pulse Pressure (2606); Pericardial Effusion (3271)

Event Date 06/23/2023

Event Type  Death  

Event Description

It was reported that during an general extraction procedure, when the physician attempted to explant this right ventricular (rv) lead, the helix perforated the myocardium, causing a pericardial effusion.The patient ended up dying during the procedure.The rv was explanted from the body and no additional adverse patient effects were reported.

Event Description

It was reported that this right ventricular (rv) lead exhibited low pacing impedances and a rise in pacing threshold measurements.Diaphragmatic stimulation was also being experienced by the patient causing the physician to suspect a perforation may have occurred.Surgical intervention was performed and during the extraction of the rv lead, the patient's blood pressure dropped, and the physician observed a hole was present in the right ventricle due to the lead being pulled out.This perforation was too large to intervene and a pericardial effusion occurred, eventually causing the patient to pass away during the procedure.The rv lead was left in situ in the body.

• 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; 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: 17367824
• MDR Text Key: 319467897
• Report Number: 2124215-2023-38587
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526531248
• UDI-Public: 00802526531248
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: 0292
• Device Catalogue Number: 0292
• Device Lot Number: 446300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Female