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); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that episode review identified stored events which were due to random noise that resembled a non-physiologic, mechanical signal on the right ventricular (rv) channel.Additionally, the amount of episodes has significantly increased over the past two months.Further details revealed that minute ventilation was disabled due to signal artifact monitor (sam).Two sam events were noted and noise was seen on both the atrial and rv electrocardiograms (egm) simultaneously.The caller confirmed the patient was having an electrophysiology study at the time of the events.A boston scientific technical services consultant concluded the first sam event was a false positive due to external source followed by a failed sensor lead check due to out of range pacing impedance measurements on the rv lead.The consultant documented and discussed the clinical observations and programming options were provided to the caller.No adverse patient effects were reported.
Event or Problem Description
It was reported that episode review identified stored events which were due to random noise that resembled a non-physiologic, mechanical signal on the right ventricular (rv) channel.Additionally, the amount of episodes has significantly increased over the past two months.Further details revealed that minute ventilation was disabled due to signal artifact monitor (sam).Two sam events were noted and noise was seen on both the atrial and rv electrocardiograms (egm) simultaneously.The caller confirmed the patient was having an electrophysiology study at the time of the events.A boston scientific technical services consultant concluded the first sam event was a false positive due to external source followed by a failed sensor lead check due to out of range pacing impedance measurements on the rv lead.The consultant documented and discussed the clinical observations and programming options were provided to the caller.No adverse patient effects were reported.It was reported that this rv lead has continued to exhibit recurrent noise with thousands of stored episodes over the past ten days.Additionally, a rv intrinsic amplitude out of range alert had been generated.Lead impedance measurements were stable in the upper 300-400 ohms range.A boston scientific technical services consultant discussed the clinical observations and programming options for this patient.The patient is only paced 1% in the rv.No adverse patient effects were reported.
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• 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): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14033365
• Report Number: 2124215-2022-08603
• Device Sequence Number: 6298629
• Product Code: DTB
• UDI-Device Identifier: 00802526265037
• UDI-Public: 00802526265037
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/18/2004
• Device Model Number: 4474
• Device Catalogue Number: 4474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2002
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male