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

Model Number 4480

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2024

Event Type  Injury  

Event Description

It was reported that this patient was hospitalized due to syncope.The device was interrogated, and it was not possible to obtain any measurements.An x-ray confirmed that this right atrial (ra) lead was dislodged.A revision was planned.During the revision it was noted that the ra lead was fractured.The lead was explanted and expected to be returned.No additional adverse patient effects were reported.

Manufacturer Narrative

This report is being filed to update the patient code.

Event Description

It was reported that this patient was hospitalized due to syncope related to a possible fall.The device was interrogated, and it was not possible to obtain any measurements and no sensing was noted.An x-ray confirmed that this right atrial (ra) lead was dislodged.A revision was planned.During the revision it was noted that the ra lead was fractured.The lead was explanted and expected to be returned.It was not confirmed if the dislodgment and fracture was related to the patients fall.No additional adverse patient effects were reported.

• Brand Name: FINELINE II STEROX
• Type of Device: 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: 19122343
• MDR Text Key: 340336339
• Report Number: 2124215-2024-23026
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): Y
• Reporter Country Code: PA
• PMA/PMN Number: P960004/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 4480
• Device Catalogue Number: 4480
• Device Lot Number: 711213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention