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

Model Number 4457

Device Problems Connection Problem (2900); Device Sensing Problem (2917)

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

Event Date 06/24/2021

Event Type  malfunction  

Event Description

It was reported that one week following a system upgrade procedure, the device was found to be exhibiting high percentages of pacing in the device rate counters.Boston scientific technical services was contacted and it was discussed that this right ventricular (rv) lead could be reversed in the header with the competitor's left ventricular (lv) lead, which could explain the observed sensing issues.Additional information has been requested regarding the event resolution, but has not yet been received.At this time, the rv lead remains implanted and no adverse consequences were reported.

Event Description

It was reported that one week following a system upgrade procedure, the device was found to be exhibiting high percentages of pacing in the device rate counters.Boston scientific technical services was contacted and it was discussed that this right ventricular (rv) lead could be reversed in the header with the competitor's left ventricular (lv) lead, which could explain the observed sensing issues.While it was originally hypothesized the leads were reversed in the device header, the physician also suspected the device counters were not appropriately reset at the implant procedure.A week later, the clinic reset the counters and bi-ventricular pacing was noted to be triggering appropriately.The event was confirmed to be resolved.At this time, the rv lead remains implanted and no adverse effects were reported.

• Brand Name: FINELINE II STEROX
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12618697
• MDR Text Key: 276904065
• Report Number: 2124215-2021-21545
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00802526060915
• UDI-Public: 00802526060915
• Combination Product (y/n): Y
• PMA/PMN Number: P960004/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/16/2015
• Device Model Number: 4457
• Device Catalogue Number: 4457
• Device Lot Number: 745224
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2021
• Patient Sequence Number: 1
• Patient Age: 88 YR