MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	0171
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This was not returned.As such, physical analysis has not been conducted in our laboratory.However, a labeling review and risk review were conducted.These reviews determined that the clinical observation of high impedance is a known inherent risk of the lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricle (rv) lead exhibited high, out of range shock impedance of great than 200 ohms.The physician reported the shock impedances to be consistently high.All other measurements are within normal range.The physician will monitor the patient closely.The device remains implanted.No adverse patient effects were reported.New information was received during a follow up appointment, lead integrity testing , at 1,1 j and shock impedance was >125ohm.The physician scheduled the patient for a lead revision procedure the next day.New information was received that this rv lead was explanted, and new one implanted.X-ray images confirmed no lead fractures.Besides surgical intervention, no adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13138627
• Report Number: 2124215-2021-38930
• Device Sequence Number: 13910969
• Product Code: LWS
• UDI-Device Identifier: 00802526373374
• UDI-Public: 00802526373374
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: P910073/S041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2022

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: 01/21/2007
• Device Model Number: 0171
• Device Catalogue Number: 0171
• Device Lot Number: 100580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 01/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown