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

Model Number 4470

Device Problems High impedance (1291); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2022

Event Type  Injury  

Event Description

It was reported that this right atrial (ra) lead was explanted and replaced due to high out-of-range pace impedance measurements greater than 3,000 ohms.No additional adverse patient effects were reported.

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.-- if information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this right atrial (ra) lead was explanted and replaced due to high out-of-range pace impedance measurements greater than 3,000 ohms.No additional adverse patient effects were reported.Additional information received reported that during the lead revision, the leader/header connections were checked.When the lead was tested with the pacing system analyzer (psa), the pace impedance measurement was 500 ohms and within normal limits.It was unclear whether the connection had contributed to the high out-of-range pace impedance measurements, however the decision was made to extract the lead.The pacemaker remains in service.It was noted that the patient was doing fine.No additional adverse patient effects were reported.

• Brand Name: FINELINE II EZ STEROX
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14138674
• MDR Text Key: 289490706
• Report Number: 2124215-2022-11596
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00802526264993
• UDI-Public: 00802526264993
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P960004/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/25/2022
• Device Model Number: 4470
• Device Catalogue Number: 4470
• Device Lot Number: 850739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male