MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0672

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Fracture (1260); High impedance (1291); Over-Sensing (1438); Failure to Sense (1559); Failure to Read Input Signal (1581)

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

Event Date 04/01/2024

Event Type  Injury  

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) right ventricular (rv) pacing and shocking lead and left ventricular (lv) lead impedance measurement was out-of-range.The patient was advised to present to the hospital after review of ventricular tachycardia (vt) and signal artifact monitor (sam) events showed noise and loss of capture (loc) on both the rv and lv leads.Device interrogation was performed, and the rv pace impedance was greater than 3,000 ohms, the rv shock impedance was greater than 200 ohms, and the lva and lvb pace impedances were both greater than 3,000 ohms.Sensing was 0.8mv (millivolts), down from 17mv in the rv but sensing was stable in the lv at greater than 25mv.There was no confirmed capture from the rv or lv leads at high outputs at 7.5v (volts).Attempts were made to reproduce lead noise and it was able to be reproduced with pocket manipulation.The rv also lost all sensing when the patient placed their right arm behind their head and signals returned when the arm was lowered (device is right sided).Imaging was performed and it did not show any obvious signs of a lead fracture.The physician made programming changes and shock therapy was disabled.The patient's underlying rhythm was stable.Technical services (ts) was consulted to review the device interrogation results.A lead fracture is suspected, and the patient will remain hospitalized until the physician decides to replace the device and/or leads.At this time, the device and this rv lead and the lv lead remain in service.No adverse patient effects were reported.

• Brand Name: RELIANCE 4-FRONT
• 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; 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: 19055973
• MDR Text Key: 339552365
• Report Number: 2124215-2024-20923
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2021
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 106851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2019
• 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
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male