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

Model Number 0673

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Perforation (2001)

Event Date 02/22/2023

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 implanted device was not working right, and the right ventricular (rv) lead was too long, and it poked through.Additional information was obtained which indicated that the patient was referred for lead revision due to suboptimal lead parameters.Moreover, there was also a concern for lead dislodgement and or micro perforation.No pericardial effusion was noted.The lead remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that the implanted device was not working right, and the right ventricular (rv) lead was too long, and it poked through.Additional information was obtained which indicated that the patient was referred for lead revision due to suboptimal lead parameters.Moreover, there was also a concern for lead dislodgement and or micro perforation.No pericardial effusion was noted.The lead remains in service.No additional adverse patient effects were reported.Additional information was obtained which indicated that the lead was revised through repositioning.The lead remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.This supplemental correction report was created to capture updates on h6: impact code and b5: describe event or problem.

• 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: 16682330
• MDR Text Key: 312698305
• Report Number: 2124215-2023-15957
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526592867
• UDI-Public: 00802526592867
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/21/2023
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 150351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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; Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female