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

Model Number 4457

Device Problems High impedance (1291); High Capture Threshold (3266)

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.A revision took place, and it was noted that the pace impedance measurements exhibited on this right ventricular (rv) lead were high and out of range as well as high pacing thresholds due to possible scarring present.The lead was not able to be repositioned as a result of the scarring.The lead was finally explanted and was expected to be returned.No adverse patient effects were reported.

Manufacturer Narrative

This report is being filed to update the describe event or problem, outcome attributed to adverse event, and patient codes.

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.A revision took place, and it was noted that the pace impedance measurements exhibited on this right ventricular (rv) lead were high and out of range as well as high pacing thresholds due to possible scarring present.The lead was not able to be repositioned as a result of the scarring.The lead was finally explanted and was expected to be returned.No 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: 19122342
• MDR Text Key: 340336322
• Report Number: 2124215-2024-23027
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

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: 4457
• Device Catalogue Number: 4457
• Device Lot Number: 861372
• 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: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization