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

Model Number 0672

Device Problems Failure to Capture (1081); Failure to Sense (1559)

Patient Problems Muscle Stimulation (1412); Perforation (2001); Twiddlers Syndrome (2114); No Code Available (3191)

Event Date 04/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this patient presented to the emergency room with phrenic nerve stimulation (pns).Device data was reviewed which revealed a slight increase in the capture threshold and shock impedance measurements from the right ventricular (rv) lead.The physician alleged a rv lead perforation had occurred.Diagnostic imaging was performed however and no obvious rv perforation was seen.It was noted the rv, left ventricular (lv) lead, and the device had been pulled and rotated from the implant site due twiddler's syndrome.The physician elected to reposition the system to resolve the event.The rv lead remains implanted and in service.The patient was stable with no additional adverse consequences.

• 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: 10253268
• MDR Text Key: 198190361
• Report Number: 2124215-2020-13326
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/09/2020

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: 07/30/2021
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 111603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 53 YR