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

Model Number	4474
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Codes	Dizziness (2194); Loss of consciousness (2418)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this pacemaker and the right ventricular (rv) lead triggered a lead safety switch (lss) due to out-of-range pace impedance measurements greater than 2,500 ohms.Approximately two weeks later, this pacemaker and the right atrial (ra) lead triggered a lead safety switch (lss) due to out-of-range pace impedance measurements greater than 2,500 ohms.Technical services (ts) discussed possible lead crush as the leads triggered the lss one after the other.Noise with oversensing was observed on both lead channels, and some of this noise appeared to be unipolar oversensing.The noise with oversensing on the rv channel also appears to have correlated with a pause of approximately seven seconds.Minute ventilation (mv) sensor oversensing was noted on the rv channel, as well.The patient also experienced lightheadedness and loss of consciousness.This pacemaker and ra lead were explanted, the rv lead was surgically abandoned, and a new system was successfully implanted.No additional adverse patient effects were reported.

• 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
• MDR Report Key: 11661593
• Report Number: 2124215-2021-05237
• Device Sequence Number: 2935697
• Product Code: DTB
• UDI-Device Identifier: 00802526265037
• UDI-Public: 00802526265037
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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: 12/16/2006
• Device Model Number: 4474
• Device Catalogue Number: 4474
• Device Lot Number: 414454
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR