MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE S; IMPLANTABLE LEAD

Model Number	0137
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	10/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this right ventricular (rv) lead was part of a system revision due to bacteremia.Reportedly, the patient presented to the hospital with a painful pocket, swelling, and discomfort.The physician started with antibiotics, sent samples for blood culture and discharge the patient.Blood cultures came back positive for staphylococcus bacteremia.There was no additional adverse patient effects were reported.This lead was explanted.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the allegation against this lead was not confirmed.This lead was analyzed, passed all the baseline tests and exhibited normal lead functions.This supplemental is being filed to capture d9: returned to manufacturer date and investigation results.
Event or Problem Description
It was reported that this right ventricular (rv) lead was part of a system revision due to bacteremia.Reportedly, the patient presented to the hospital with a painful pocket, swelling, and discomfort.The physician started with antibiotics, sent samples for blood culture and discharged the patient.Blood cultures came back positive for staphylococcus bacteremia.There was no additional adverse patient effects were reported.This lead was explanted.

• Brand Name: ENDOTAK RELIANCE S
• Common Device Name: 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: 20626915
• Report Number: 2124215-2024-70038
• Device Sequence Number: 12988192
• Product Code: LWS
• UDI-Device Identifier: 00802526531101
• UDI-Public: 00802526531101
• Combination Product (Y/N): Y
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/12/2024
• Device Model Number: 0137
• Device Catalogue Number: 0137
• Device Lot Number: 301379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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: 43 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White