MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; IMPLANTABLE LEAD

Model Number	4458
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker exhibited high out-of-range (oor) right ventricular (rv) pacing impedances measuring greater than 3000 ohms.A lead safety switch (lss) was also declared which switched the pace/sense configuration from bipolar to unipolar.When the device was in unipolar there were observations of noise.Additionally, there was a stored false signal artifact (sam) episode due to atrial driven rates.The health care professional (hcp) programmed the minute ventilation feature to passive and accelerometer only.At this time, the pacemaker and rv lead remain in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker exhibited high out-of-range (oor) right ventricular (rv) pacing impedances measuring greater than 3000 ohms.A lead safety switch (lss) was also declared which switched the pace/sense configuration from bipolar to unipolar.When the device was in unipolar there were observations of noise.Additionally, there was a stored false signal artifact (sam) episode due to atrial driven rates.The health care professional (hcp) programmed the minute ventilation feature to passive and accelerometer only.At this time, the pacemaker and rv lead remain in service.No adverse patient effects were reported.This supplemental is being filed as additional information was received which reported that this right ventricular (rv) lead was surgically abandoned and replaced successfully.The pacemaker remains in service.No additional adverse patient effects were reported.

• Brand Name: FINELINE II STEROX
• Common Device Name: IMPLANTABLE LEAD
• 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: 12271889
• Report Number: 2124215-2021-22751
• Device Sequence Number: 4101165
• Product Code: DTB
• UDI-Device Identifier: 00802526060953
• UDI-Public: 00802526060953
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• 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): 07/18/2023

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: 04/05/2003
• Device Model Number: 4458
• Device Catalogue Number: 4458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2001
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male