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

Model Number	0665
Medical Device Problem Codes	Defective Device (2588); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high pacing thresholds.During a scheduled check-up, the patient's heart rate dropped, and device output was increased to ensure capture.Moreover, a chest x-ray was done, and dislodgement was confirmed.Subsequently, the patient underwent a pocket revision, and the physician tried to move the lead back in place but was unsuccessful.This rv lead was explanted, and a new lead was placed.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.Upon receipt at our post market quality assurance laboratory, detailed analysis indicated that the allegations were not confirmed despite the hv cable damage noted which likely occurred during revision/explant.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high pacing thresholds.During a scheduled check-up, the patient's heart rate dropped, and device output was increased to ensure capture.Moreover, a chest x-ray was done, and dislodgement was confirmed.Subsequently, the patient underwent a pocket revision, and the physician tried to move the lead back in place but was unsuccessful.This rv lead was explanted, and a new lead was placed.No additional adverse patient effects were reported.

• Brand Name: RELIANCE 4-FRONT
• Common Device Name: 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: 14246515
• Report Number: 2124215-2022-13840
• Device Sequence Number: 14537645
• Product Code: LWS
• UDI-Device Identifier: 00802526496967
• UDI-Public: 00802526496967
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/26/2021
• Device Model Number: 0665
• Device Catalogue Number: 0665
• Device Lot Number: 501689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Female