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

Model Number	0128
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device remains implanted and out of service; therefore, physical analysis is unable to be conducted.Without laboratory analysis, it is not possible to definitively determine how the device may have contributed to the complaint incident.(b)(4).
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a high out-of-range pace impedance measurement of 2,500 ohms.There was also an increase in the pacing threshold measurement.No loss of capture was reported.Subsequently, this patient underwent a revision procedure, and this rv lead was surgically capped/abandoned.It was noted there was no evidence of a lead fracture on x-ray imaging.A new rv lead was successfully placed.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE S
• Common Device Name: DEFIBRILLATOR / PACEMAKER LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11105110
• Report Number: 2124215-2020-25777
• Device Sequence Number: 631563
• Product Code: LWS
• UDI-Device Identifier: 00802526085505
• UDI-Public: 00802526085505
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2021

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: 02/08/2010
• Device Model Number: 0128
• Device Catalogue Number: 0128
• Device Lot Number: 105625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 01/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention