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

Model Number	0286
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	03/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system exhibited right ventricular (rv) loss of capture when programmed at maximum outputs.Additionally, the patient was experiencing hypotension.Subsequently, the icd was explanted and replaced, and a temporary rv lead was used, and a new rv lead was implanted.The existing rv lead was surgically abandoned and replaced successfully.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system exhibited right ventricular (rv) loss of capture when programmed at maximum outputs.Additionally, the patient was experiencing hypotension.Subsequently, the icd was explanted and replaced, and a temporary rv lead was used, and a new rv lead was implanted.The existing rv lead was surgically abandoned and replaced successfully.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Correction to field h6 impact codes.

• Brand Name: ENDOTAK RELIANCE G
• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16618639
• Report Number: 2124215-2023-14203
• Device Sequence Number: 20356903
• Product Code: NVY
• UDI-Device Identifier: 00802526431418
• UDI-Public: 00802526431418
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/19/2023

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: 05/05/2019
• Device Model Number: 0286
• Device Catalogue Number: 0286
• Device Lot Number: 392900
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male