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

Model Number	0171
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a troubleshooting, noisy signals were oversensed in the right ventricular (rv) channel.Pectoral myopotentials maneuvers were positive, as a result, the physician decided to adjust the sensitivity and to continue to monitor the patient via latitude monitor system.No reported asystole.At this time, this system remains in service.No adverse patient effects were reported.Additional information confirmed that on april 6th, provocative maneuvers were performed and pectoral myopotentials reproduced and marked as vt.The physician decided to extract the lead soon in another hospital.Boston scientific technical services boston scientific technical analyzed the data and conclude that there are tow sets of noise, one could be due to the rv to can vector for the hv egm and the other signal is very regular and cyclic in nature usually indicative of some sort of emi.On may 12th, the lead was explanted.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12221258
• Report Number: 2124215-2021-19853
• Device Sequence Number: 4477627
• Product Code: LWS
• UDI-Device Identifier: 00802526373374
• UDI-Public: 00802526373374
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2021

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: 02/12/2009
• Device Model Number: 0171
• Device Catalogue Number: 0171
• Device Lot Number: 101171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 07/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention