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

Model Number 0692

Device Problems Failure to Capture (1081); Pacing Problem (1439); Failure to Sense (1559); Low impedance (2285); Device Dislodged or Dislocated (2923)

Patient Problem Twiddlers Syndrome (4563)

Event Date 09/14/2021

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) lead was initially thought to have insulation damage due to low pacing impedances, however additional testing was performed including an x-ray that determined that this lead was dislodged into the right atrium/high right ventricle due to twiddler syndrome of this device.The patient was hospitalized due to observations of loss of capture, inappropriate/ineffective pacing and sensing issues in order to be monitored externally until a revision can be performed.Subsequently, the device was explanted and replaced, however the rv lead was isolated and unable to be explanted so surgically capped and replaced.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; road 698, lot no. 12; dorado PR 00646 ; * 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13270938
• MDR Text Key: 283966579
• Report Number: 2124215-2022-00335
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: AU
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/20/2020
• Device Model Number: 0692
• Device Catalogue Number: 0692
• Device Lot Number: 544634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention