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

Model Number	0170
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.(b)(4).
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted due to an increased on the pacing thresholds.This lead was replaced.A surgical intervention was necessary to resolve the issue.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.Patient code 3191 captures the reportable event of surgery.
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted due to an increased on the pacing thresholds.This lead was replaced.A surgical intervention was necessary to resolve the issue.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: 9924658
• Report Number: 2124215-2020-04384
• Device Sequence Number: 3354600
• Product Code: LWS
• UDI-Device Identifier: 00802526373282
• UDI-Public: 00802526373282
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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: 01/28/2017
• Device Model Number: 0170
• Device Catalogue Number: 0170
• Device Lot Number: 101409
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR