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

Model Number	0128
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Material Integrity Problem (2978); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular lead was partially abandoned due to unknown product performance issue.Additional information provided indicates that this lead's pace/sense portion was surgically abandoned as the lead has been under observation by the clinic since march of 2020 due to increasing high out of range pacing impedances.Also, this lead exhibited noise on a stored event, as well as rising thresholds.In addition, it was suspected by the physician that the lead was potentially damaged due to subclavian crush, however, there were no visible signs of fracture or crush observed under fluoroscopy.Subsequently, during the pulse generator change out due to elective replacement indicator, this lead was fixed and the shocking portion remains in service.A new pace/sense lead was implanted to substitute the abandoned pace/sense portion.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE S
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11662255
• Report Number: 2124215-2021-06485
• Device Sequence Number: 2730296
• Product Code: LWS
• UDI-Device Identifier: 00802526085505
• UDI-Public: 00802526085505
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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: 02/11/2013
• Device Model Number: 0128
• Device Catalogue Number: 0128
• Device Lot Number: 106001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR