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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

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BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER Back to Search Results
Model Number U228
Device Problems High impedance (1291); Pacing Problem (1439)
Patient Problem Unspecified Heart Problem (4454)
Event Date 11/06/2023
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system triggered a lead safety switch (lss) due to left ventricular (lv) lead impedance high out of range, measurement of 2027 ohms.Technical services (ts) was consulted and noted pacemaker mediated tachycardia (pmt) episodes were also recorded.This crt-p system remains in service.The patient reported feeling palpitations.No adverse patient effects were reported.
 
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Brand Name
VISIONIST X4 CRT-P
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
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 Key18266480
MDR Text Key329726307
Report Number2124215-2023-68754
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559471
UDI-Public00802526559471
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number782200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age78 YR
Patient SexFemale
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