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

Model Number	0187
Medical Device Problem Codes	High impedance (1291); Off-Label Use (1494)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the device replacement procedure when the right ventricular (rv) lead was connected to the new implantable cardioverter defibrillator (icd) high out of range shock impedances measuring greater than 125 ohms were exhibited.When the shock lead vector was programmed distal coil to can the impedances were out of range.The proximal terminal pin was connected to the distal port and the distal terminal pin was connected to the proximal port.When the leads were reversed in the header the shock impedances were within normal limits.Boston scientific technical services (ts) discussed since the device is implanted in the abdomen this may be a workable vector, however, they recommended performing defibrillation threshold (dft) testing to confirm.Subsequently, dft testing was performed and the patient's rhythm was successfully converted.This icd was successfully implanted and remains in service.The rv lead also remains in service.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE G
• Common Device Name: IMPLANTABLE DEFIBRILLATION LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8510860
• Report Number: 2124215-2019-05553
• Device Sequence Number: 11171066
• Product Code: LWS
• UDI-Device Identifier: 00802526531217
• UDI-Public: 00802526531217
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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: Health Professional
• Device Expiration Date: 01/28/2013
• Device Model Number: 0187
• Device Catalogue Number: 0187
• Device Lot Number: 300226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR