MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE S; DEFIBRILLATOR / PACEMAKER LEAD

Model Number	0128
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out of range shock impedance measurements, measuring greater than 125 ohms.X-ray imaging was unremarkable, and in-clinic manipulations have been unsuccessful at reproducing the high impedance measurements.Boston scientific technical services (ts) provided additional lead integrity testing to rule out lead impairment.No adverse patient effects were reported.At this time, this rv lead remains in service.
Additional Manufacturer Narrative
This device remains implanted; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out of range shock impedance measurements, measuring greater than 125 ohms.X-ray imaging was unremarkable, and in-clinic manipulations have been unsuccessful at reproducing the high impedance measurements.Boston scientific technical services (ts) provided additional lead integrity testing to rule out lead impairment.No adverse patient effects were reported.At this time, this rv lead remains in service.Additional information from the field indicates no programming changes have been made at present, and this patient will be closely monitored via the latitude remote patient monitoring system.

• Brand Name: ENDOTAK RELIANCE S
• Common Device Name: DEFIBRILLATOR / PACEMAKER LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10636942
• Report Number: 2124215-2020-19140
• Device Sequence Number: 19471476
• Product Code: LWS
• UDI-Device Identifier: 00802526085505
• UDI-Public: 00802526085505
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: 07/22/2005
• Device Model Number: 0128
• Device Catalogue Number: 0128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1