MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	0266
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) defibrillation lead exhibited a gradual increase in pacing impedance measurements eventually resulting in high out of range measurements greater than 2,000 ohms.Calcification on the lead tip was suspected.Boston scientific technical services (ts) discussed the option of increasing the alert value in the remote home monitoring system and continuing monitoring.The physician opted to increase the alert value in the remote home monitoring system and monitoring will be continued.No adverse patient effects were reported.This product remains implanted and in service.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10620196
• Report Number: 2124215-2020-16618
• Device Sequence Number: 3004335
• Product Code: NVY
• UDI-Device Identifier: 00802526431296
• UDI-Public: 00802526431296
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2020

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: 04/15/2015
• Device Model Number: 0266
• Device Catalogue Number: 0266
• Device Lot Number: 100512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 10/02/2020
• Patient Sequence Number: 1
• Patient Age: 84 YR