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

Model Number	0148
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); Impedance Problem (2950)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular lead exhibited poor impedance trends and jumps in impedance leading to suspicion of lead fracture.During the extraction procedure the superior vena cava was torn, and a procedure was performed to repair it.This lead was surgically abandoned, and the replacement procedure was postponed.Subsequently a subcutaneous implantable cardioverter defibrillator implant procedure was successfully performed.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular lead exhibited poor impedance trends and jumps in impedance leading to suspicion of lead fracture.During the extraction procedure the superior vena cava was torn, and a procedure was performed to repair it.This lead was surgically abandoned, and the replacement procedure was postponed.Subsequently a subcutaneous implantable cardioverter defibrillator implant procedure was successfully performed.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular lead exhibited poor impedance trends and jumps in impedance leading to suspicion of lead fracture.It was also noted that no breaks were noted through fluoroscopy, however isometrics reflected impedance change and noise.During the extraction procedure the superior vena cava was torn, and a procedure was performed to repair it.This lead was surgically abandoned, and the replacement procedure was postponed.Subsequently a subcutaneous implantable cardioverter defibrillator implant procedure was successfully performed.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• 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: 19088797
• Report Number: 2124215-2024-22142
• Device Sequence Number: 7099449
• Product Code: LWS
• UDI-Device Identifier: 00802526085918
• UDI-Public: 00802526085918
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2024

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: 09/09/2011
• Device Model Number: 0148
• Device Catalogue Number: 0148
• Device Lot Number: 160923
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 03/28/2024; 07/09/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 04/17/2024; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2009
• 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; Life Threatening; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female