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

Model Number	0171
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular (rv) pace impedance was out of range at 2,267 ohms.The impedance had been gradually rising and was greater than 2,000 ohms on multiple occasions.All other lead measurements were as expected.Technical services recommended increasing the impedance alert on the implantable cardioverter defibrillator to 2,500 ohms.The rv lead remains in service and no adverse patient effects were reported.
Event or Problem Description
It was reported that the right ventricular (rv) pace impedance was out of range at 2,267 ohms.The impedance had been gradually rising and was greater than 2,000 ohms on multiple occasions.All other lead measurements were as expected.Technical services (ts) recommended increasing the impedance alert on the implantable cardioverter defibrillator to 2,500 ohms.The rv lead remains in service and no adverse patient effects were reported.It was additionally reported that the rv capture threshold was also increasing.Shock impedance was stable, sensing was good and no signal noise was noted.Ts recommended further troubleshooting in clinic.
Event or Problem Description
It was reported that the right ventricular (rv) pace impedance was out of range at 2,267 ohms.The impedance had been gradually rising and was greater than 2,000 ohms on multiple occasions.All other lead measurements were as expected.Technical services (ts) recommended increasing the impedance alert on the implantable cardioverter defibrillator to 2,500 ohms.Additionally reported that the rv capture threshold was also increasing.Shock impedance was stable, sensing was good and no signal noise was noted.Ts recommended further troubleshooting in clinic.Another additional information was received which indicated this rv lead was surgically abandoned and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the right ventricular (rv) pace impedance was out of range at 2,267 ohms.The impedance had been gradually rising and was greater than 2,000 ohms on multiple occasions.All other lead measurements were as expected.Technical services (ts) recommended increasing the impedance alert on the implantable cardioverter defibrillator to 2,500 ohms.The rv lead remains in service and no adverse patient effects were reported.It was additionally reported that the rv capture threshold was also increasing.Shock impedance was stable, sensing was good and no signal noise was noted.Ts recommended further troubleshooting in clinic.Additional information was received which indicated this rv lead was surgically abandoned and replaced due to high impedance out of range, high pacing thresholds and oversensing.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
• 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: 12054979
• Report Number: 2124215-2021-14176
• Device Sequence Number: 19744833
• Product Code: LWS
• UDI-Device Identifier: 00802526373374
• UDI-Public: 00802526373374
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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,Followup
• Report Date (Section B): 01/16/2023

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: 10/25/2012
• Device Model Number: 0171
• Device Catalogue Number: 0171
• Device Lot Number: 103310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 02/18/2022; 01/06/2023; 01/06/2023
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 04/16/2022; 01/11/2023; 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2010
• 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; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male