MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD

Model Number 0673

Device Problems Failure to Capture (1081); Mechanical Problem (1384); Contamination /Decontamination Problem (2895)

Patient Problems Pericardial Effusion (3271); Syncope/Fainting (4411); Asystole (4442)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) and a right ventricular (rv) lead was admitted to the hospital with a syncopal episode.A chest x ray analysis was completed and showed the crt-d had moved inferiorly, putting tension on the leads.The rv lead did not capture at maximum output.A non-bsc left ventricular (lv) lead did not capture the left bundle branch, only the rv septum.The patient developed a pericardial effusion; therefore, a pericardial window procedure was completed.Afterwards, the patient underwent a lead revision, nevertheless a new rv lead was required as the initial rv lead showed helix retraction mechanical difficulties while being revised.Tissue was found trapped in the helix.The non bsc lv lead dislodged during the procedure and patient went asystole.Cardiopulmonary resuscitation was performed for a few minutes while a temporary pacing wire was placed.The dislodged non bsc lead was removed, and a new one was placed in the high rv septum.The pocket was closed and discharged.The explanted rv lead has been returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.The helix was retracted and dried body fluid and possibly tissue were noted in the helix housing.Cuts in insulation were noted but likely due to explant damage.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) and a right ventricular (rv) lead was admitted to the hospital with a syncopal episode.A chest x ray analysis was completed and showed the crt-d had moved inferiorly, putting tension on the leads.The rv lead did not capture at maximum output.A non-bsc left ventricular (lv) lead did not capture the left bundle branch, only the rv septum.The patient developed a pericardial effusion; therefore, a pericardial window procedure was completed.Afterwards, the patient underwent a lead revision, nevertheless a new rv lead was required as the initial rv lead showed helix retraction mechanical difficulties while being revised.Tissue was found trapped in the helix.The non bsc lv lead dislodged during the procedure and patient went asystole.Cardiopulmonary resuscitation was performed for a few minutes while a temporary pacing wire was placed.The dislodged non bsc lead was removed, and a new one was placed in the high rv septum.The pocket was closed and discharged.The explanted rv lead has been returned for analysis.No additional adverse patient effects were reported.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE LEAD
• 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: 18755437
• MDR Text Key: 335933467
• Report Number: 2124215-2024-10527
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526592867
• UDI-Public: 00802526592867
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

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 Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 213293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 03/30/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female