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

Model Number	0186
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient with this implantable cardioverter defibrillator (icd) exhibited high out of range pace impedance measurements, measuring greater than 2000 ohms.In addition, there was noise observed on the right ventricular (rv) shock channel.The plan is to continue to monitor at this time.The device system remains in service.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE G
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11356153
• Report Number: 2124215-2021-03227
• Device Sequence Number: 4959914
• Product Code: LWS
• UDI-Device Identifier: 00802526531200
• UDI-Public: 00802526531200
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/30/2017
• Device Model Number: 0186
• Device Catalogue Number: 0186
• Device Lot Number: 302361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR