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

Model Number	0187
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) lead exhibited high out-of-range shock impedance of greater than 200 ohms.Boston scientific technical services (ts) recommended bringing the patient into the clinic for further evaluation including isometrics.This product remains in service no adverse patient effects were reported.
Event or Problem Description
Additional information was received that noise and oversensing were also noted on the rv lead.A lead revision / extraction procedure was scheduled.This crt-d and rv lead were explanted.No additional adverse patient effects were reported.
Event or Problem Description
Additional information was received that the crt-d was returned and analyzed.Analysis results suggest the out-of-range shock impedance measurements were due to a fractured df-1+ header wire on the device.Thus the issue does not appear to be related to this rv lead.The rv lead is out-of-service.No additional 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: 8002688
• Report Number: 2124215-2018-60130
• Device Sequence Number: 13740881
• Product Code: LWS
• UDI-Device Identifier: 00802526531217
• UDI-Public: 00802526531217
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2019

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: 01/14/2012
• Device Model Number: 0187
• Device Catalogue Number: 0187
• Device Lot Number: 300091
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 10/11/2018; 03/06/2019
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/05/2018; 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR