MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; DEFIBRILLATOR / PACEMAKER LEAD

Model Number	0158
Medical Device Problem Codes	High impedance (1291); Connection Problem (2900)
Health Effect - Clinical Codes	Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this right ventricular (rv) lead recently underwent a device replacement procedure, and the new implantable cardioverter defibrillator (icd) was positioned on the right side.All rv lead measurements after implant were fine.It was noted that the implanting physician struggled to get the previous device out of the pocket and make the leads free enough to connect everything again.The physician was very thorough, and even connected the shock coil twice in order to verify insertion.The next morning, the shock impedance was observed to be greater than 200 ohms.Technical services was consulted and reviewed both device data and available images, and defibrillation threshold (dft) testing was recommended.The following week, dft was performed and was successful.This rv lead remains in service, and there were no associated patient symptoms reported.
Event or Problem Description
It was reported that the patient with this right ventricular (rv) lead recently underwent a device replacement procedure, and the new implantable cardioverter defibrillator (icd) was positioned on the right side.All rv lead measurements after implant were fine.It was noted that the implanting physician struggled to get the previous device out of the pocket and make the leads free enough to connect everything again.The physician was very thorough, and even connected the shock coil twice in order to verify insertion.The next morning, the shock impedance was observed to be greater than 200 ohms.Technical services was consulted and reviewed both device data and available images, and defibrillation threshold (dft) testing was recommended.The following week, dft was performed and was successful.This rv lead remains in service, and there were no associated patient symptoms reported.
Additional Manufacturer Narrative
This lead remains implanted; therefore, technical analysis cannot be conducted.Without a returned product it is not possible to definitively confirm how it may have contributed to the complaint incident.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: DEFIBRILLATOR / PACEMAKER LEAD
• 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: 16594956
• Report Number: 2124215-2023-13628
• Device Sequence Number: 19556393
• Product Code: LWS
• UDI-Device Identifier: 00802526531132
• UDI-Public: 00802526531132
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• PMA/510(K) Number: P910073/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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: 02/16/2006
• Device Model Number: 0158
• Device Catalogue Number: 0158
• Device Lot Number: 138075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2004
• 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: Other
• Patient Sex: Unknown