MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; PERMANENT PACEMAKER ELECTRODE

Model Number	4459
Medical Device Problem Codes	Failure to Capture (1081); Material Integrity Problem (2978)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient implanted with this right ventricular (rv) lead was admitted to the hospital due to syncope.Interrogation of the associated pacemaker confirmed normal device function however the bedside cardiac monitor showed loss of capture (loc).Isometrics were unable to create any noise.An x-ray revelated what appears to be clavicular first rib crush.Intervention is pending to replace the lead.

• Brand Name: FINELINE II STEROX
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• 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: 13377549
• Report Number: 2124215-2021-40260
• Device Sequence Number: 19752721
• Product Code: DTB
• UDI-Device Identifier: 00802526061004
• UDI-Public: 00802526061004
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2022

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: 11/14/2015
• Device Model Number: 4459
• Device Catalogue Number: 4459
• Device Lot Number: 485216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2013
• 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: Hospitalization; Required Intervention
• Patient Sex: Female