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

Model Number U225

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 05/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac re-synchronization therapy pacemaker (crt-p) exhibited high, out-of-range pacing impedance measurements on the non-boston scientific left ventricular (lv) lead.The lead safety switch (lss) caused the lead to switch to the unipolar configuration.The device was reprogrammed to turn off lv autocapture, and the minute ventilation (mv) sensor.No adverse patient effects were reported.Additional information was received after the patient's next follow-up.It was reported the lv lead was programmed to unipolar pacing, and bipolar sensing.Lead measurements were within normal limits, and no noise was created with isometric movement.The patient reported feeling well, but noted feeling stimulation from the lv lead.This occurred rarely, and lasted no longer than 20 seconds.The device and lead remained 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: 10752685
• MDR Text Key: 213663922
• Report Number: 2124215-2020-22311
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559426
• UDI-Public: 00802526559426
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/29/2021
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 712748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR