MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U225

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Device Sensing Problem (2917)

Patient Problem No Code Available (3191)

Event Date 04/04/2020

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.(b)(4).

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) detected high out-of-range right atrial (ra) lead impedance measurements resulting in a lead safety switch from bipolar to unipolar.The unipolar ra pacing impedance measurement was within normal limits.A review of stored episodes noted an isolated incident of oversensed noise however no noise could be produced with in clinic provocations.The clinician noted that the right ventricular (rv) lead threshold measurements had increased so the pulse width was changed.No adverse patient effects were reported.The device remains implanted and in service.

• Brand Name: VISIONIST CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10227950
• MDR Text Key: 197597175
• Report Number: 2124215-2020-11808
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559426
• UDI-Public: 00802526559426
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/24/2017
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 700844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR