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

Model Number	4459
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device has not been returned; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited noise and oversensing.Subsequently, lead revision was performed, and it was noted the oversensing of noise appeared to be resolved post revision.However, more recently, the rv lead exhibited noise and oversensing once again.Technical services (ts) was consulted and confirmed the noise and oversensing, and also noted a recent lead safety switch (lss) due to low rv pace impedance.Information later received indicates the hcp has since decided to send the patient to a different hospital for a future lead replacement procedure.The local area field representative was not provided any further information beyond this.

• Brand Name: FINELINE II STEROX
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12514750
• Report Number: 2124215-2021-20014
• Device Sequence Number: 19682669
• Product Code: DTB
• UDI-Device Identifier: 00802526061004
• UDI-Public: 00802526061004
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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: 06/10/2011
• Device Model Number: 4459
• Device Catalogue Number: 4459
• Device Lot Number: 468237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 09/22/2021
• 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: 71 YR