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

Model Number	0186
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	03/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) has exhibited high out of range shock impedance measurements on this right ventricular (rv) lead.Additionally, the patient experienced a syncopal event and was evaluated in a hospital setting.Upon review, no stored episodes were found on the device.Further testing was recommended regarding this lead.No additional adverse patient effects were reported.At this time, this device system remains in service.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) has exhibited high out of range shock impedance measurements on this right ventricular (rv) lead.Additionally, the patient experienced a syncopal event and was evaluated in a hospital setting.Upon review, no stored episodes were found on the device.Further testing was recommended regarding this lead.Additional information was received that the cause of the out of range measurements could not be determined but a lead damage was suspected.No additional adverse patient effects were reported.At this time, this device system remains in service.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) has exhibited high out of range shock impedance measurements on this right ventricular (rv) lead.Additionally, the patient experienced a syncopal event and was evaluated in a hospital setting.Upon review, no stored episodes were found on the device.Further testing was recommended regarding this lead.Additional information was received that the cause of the out of range measurements could not be determined but a lead damage was suspected.Further information was received that this lead exhibited noise artifact that may be from medical procedure and/or electromagnetic interference (emi).No additional adverse patient effects were reported.At this time, this device system remains in service.

• Brand Name: ENDOTAK RELIANCE G
• 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: 16659481
• Report Number: 2124215-2023-15323
• Device Sequence Number: 7171994
• Product Code: LWS
• UDI-Device Identifier: 00802526531200
• UDI-Public: 00802526531200
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/23/2012
• Device Model Number: 0186
• Device Catalogue Number: 0186
• Device Lot Number: 300861
• 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: 03/26/2023
• Supplement Date Received by Manufacturer: 04/12/2023; 09/28/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/18/2023; 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2010
• 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
• Patient Age: 61 YR
• Patient Sex: Male