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

Model Number 0672

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Failure to Read Input Signal (1581); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problems Muscle Stimulation (1412); Palpitations (2467); Cardiac Perforation (2513); No Code Available (3191); Pericardial Effusion (3271)

Event Date 08/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The related investigation determined that this lead was associated with a reported perforation with no conclusive evidence of a malfunction; please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that the patient was presented to the clinic due to discomfort and palpitation since implant.Upon device interrogation, the device exhibited loss of capture (loc), poor sensing amplitude, low impedance, and high capture threshold.Additionally, an echocardiogram was performed and showed pericardial effusion.This right ventricular (rv) lead has perforated.Additional information was received, stating that the patient underwent a revision procedure.During the procedure, a xiphoid sternotomy was performed to prevent significant pericardial effusion or tamponade.The rv lead was successfully repositioned with good measurements.The xiphoid sternotomy was closed with the pericardial drain still in place.No additional adverse patient effects were reported.Additional information: after the reposition intervention, there was an alert for rv threshold suspension.The lead's daily measurement showed a significant drop in r-wave and failed automatic threshold test.The electrogram (egm) showed signs of loss of capture (loc) and intermittent far-field oversensing.A computerized tomography (ct) scan was performed and revealed that the rv lead was dislodged and retracted back to the level of tricuspid valve.The device therapy was programmed off to wait for additional intervention.Subsequently, the patient underwent surgical intervention the next day to explant and replace the rv lead.Another rv was successfully implanted.No additional 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10752610
• MDR Text Key: 213634058
• Report Number: 2124215-2020-22318
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/22/2021
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 111296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• 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): Hospitalization; Required Intervention