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

Model Number	0170
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Electric Shock (2554); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2019
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.
Event or Problem Description
It was reported that this lead exhibited out of range shock impedance.Lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this lead exhibited out of range shock impedance.Lead remains in service.No adverse patient effects were reported.After three years additional information was received indicating shock impedance is still high out of range.It was recommended to deliver commanded shock or change threshold to 150 ohms and continue monitoring.
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.
Additional Manufacturer Narrative
Additional information was added to the following fields: b1: adverse event/product problem b2: outcome attributed to adverse event b5: describe event or problem field h1: type of reportable event h6: patient codes h6: impact codes information was corrected from the following fields: e3: initial reporter phone e3: occupation g2: report source.
Event or Problem Description
It was reported that this lead exhibited out of range shock impedance.Lead remains in service.No adverse patient effects were reported.After three years additional information was received indicating shock impedance is still high out of range.It was recommended to deliver commanded shock or change threshold to 150 ohms and continue monitoring.Additional information was received detailing that a commanded shock was performed in order to evaluate the lead.It was decided to continue using the lead and the patient will continue to be monitored.

• Brand Name: ENDOTAK RELIANCE SG
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9547838
• Report Number: 2124215-2019-25085
• Device Sequence Number: 2334273
• Product Code: LWS
• UDI-Device Identifier: 00802526373282
• UDI-Public: 00802526373282
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2023

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: 10/09/2011
• Device Model Number: 0170
• Device Catalogue Number: 0170
• Device Lot Number: 100480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 07/05/2022; Not provided
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 07/27/2022; 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female