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

Model Number 4469

Device Problems Failure to Capture (1081); High impedance (1291); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2019

Event Type  Injury  

Event Description

It was reported that this right atrial (ra) lead exhibited impedance measurements of greater than 3000 ohms and loss of capture.Boston scientific technical services (ts) discussed this and it was noted this would be discussed further with the clinic.No adverse patient effects were reported.The lead remains in service.

Event Description

Additional information received reported that ra deflections were noted.A surgical revision was performed, during which the lead fell out of the device header.The lead measurements were good; therefore the lead was connected to the device.The lead remains in service.No additional adverse patient effects were reported.

• Brand Name: FINELINE II EZ STEROX
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9549954
• MDR Text Key: 174272025
• Report Number: 2124215-2019-25821
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00802526265143
• UDI-Public: 00802526265143
• Combination Product (y/n): N
• PMA/PMN Number: P960004/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/08/2019
• Device Model Number: 4469
• Device Catalogue Number: 4469
• Device Lot Number: 603205
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR