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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
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.
 
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Brand NameVISIONIST CRT-P
Type of DevicePULSE 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 Key10752685
MDR Text Key213663922
Report Number2124215-2020-22311
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/29/2021
Device Model NumberU225
Device Catalogue NumberU225
Device Lot Number712748
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/16/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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