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

Model Number	0665
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high threshold measurements along with loss of capture (loc) on the presenting electrogram (egm).This patient was not pacemaker dependent at that time.Technical services (ts) recommended to consider a chest x ray.The x ray was obtained which did not show a rv lead issue rather a left ventricular (lv) lead that was under inserted.It was noted that this patient has comorbidities specifically esophageal cancer and his life expectancy maybe not exceed the device longevity.The field representative will leave it up to the physician as to the future plan for this patient regarding possible programming changes or surgical intervention.This rv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high threshold measurements along with loss of capture (loc) on the presenting electrogram (egm).This patient was not pacemaker dependent at that time.Technical services (ts) recommended to consider a chest x ray.The x ray was obtained which did not show a rv lead issue rather a left ventricular (lv) lead that was under inserted.It was noted that this patient has comorbidities specifically esophageal cancer and his life expectancy maybe not exceed the device longevity.The field representative will leave it up to the physician as to the future plan for this patient regarding possible programming changes or surgical intervention.This rv lead remains in service.No adverse patient effects were reported.Additional information was received that this patient went for a revision procedure in which the pocket was opened, and the lv lead was pulled out, cleaned up and reinserted the pin.The lv lead was noted to be working well again and it was confirmed to be a set screw issue.This rv lead remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: 18526218
• Report Number: 2124215-2024-02171
• Device Sequence Number: 15350071
• Product Code: LWS
• UDI-Device Identifier: 00802526496967
• UDI-Public: 00802526496967
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/27/2024
• Device Model Number: 0665
• Device Catalogue Number: 0665
• Device Lot Number: 510366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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: 72 YR
• Patient Sex: Male