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

Model Number 4459

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Connection Problem (2900); High Capture Threshold (3266)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2020

Event Type  Injury  

Manufacturer Narrative

This investigation is complete.Upon further information this investigation will be updated.

Event Description

It was reported that high out of range pace impedance measurements were exhibited as well noise during arm movements when it comes to this device and right ventricular (rv) lead.A fracture or insulation damage was suspected when it comes to this rv lead.A revision took place and upon opening the pocket a connection issue confirmed.The rv lead was reconnected to the device and the wound was closed with no issues.No adverse patient 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
• 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: 10222047
• MDR Text Key: 197285403
• Report Number: 2124215-2020-08800
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00802526061004
• UDI-Public: 00802526061004
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P960004/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/11/2010
• Device Model Number: 4459
• Device Catalogue Number: 4459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention