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

Model Number	4458
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the lead safety switch was triggered on the right ventricular (rv) lead due to out-of-range impedance, which resulted in noise on the rv channel due to the change to unipolar programming.The pacemaker was programmed to dual chamber pacing without sensing.There was loss of capture at 2.0 v and capture was achieved once a high output was obtained; however, the physician elected to implant a leadless pacemaker (non-boston scientific product) rather than do an rv lead revision.It is unknown if the rv lead remains implanted.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
• MDR Report Key: 12114236
• Report Number: 2124215-2021-17864
• Device Sequence Number: 4898337
• Product Code: DTB
• UDI-Device Identifier: 00802526060953
• UDI-Public: 00802526060953
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 07/04/2021

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: 02/16/2012
• Device Model Number: 4458
• Device Catalogue Number: 4458
• Device Lot Number: 419881
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 07/04/2021
• 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: 74 YR