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

Model Number	4474
Medical Device Problem Codes	Pacing Problem (1439); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is expected for return.Following completion of laboratory analysis, this event will be further updated.
Event or Problem Description
It was reported that this right ventricular (rv) lead dislodged, causing pacing to be compromised.Subsequently, the patient was immediately hospitalized, and surgical intervention was performed to explant and replace this lead.No additional adverse patient effects were reported.This lead is expected for return.Additional information: a good faith effort was submitted to the field to obtain more detailed information regarding what type of pacing issues were a result of the dislodgment.At this time, no further information has been provided.
Event or Problem Description
It was reported that this right ventricular (rv) lead dislodged, causing pacing to be compromised.Subsequently, the patient was immediately hospitalized, and surgical intervention was performed to explant and replace this lead.No additional adverse patient effects were reported.This lead was received for analysis.
Additional Manufacturer Narrative
Based on the available information, boston scientific concludes that although this lead passed all available testing, this event occurred as a result of a known and documented possible adverse consequence.

• Brand Name: FINELINE II EZ 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16216460
• Report Number: 2124215-2023-02221
• Device Sequence Number: 17640041
• Product Code: DTB
• UDI-Device Identifier: 00802526265037
• UDI-Public: 00802526265037
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: 06/22/2022
• Device Model Number: 4474
• Device Catalogue Number: 4474
• Device Lot Number: 441507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female