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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P IMPLANTABLE DEVICE

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BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P IMPLANTABLE DEVICE Back to Search Results
Model Number U228
Device Problems Pacing Problem (1439); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2022
Event Type  Injury  
Event Description
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) was implanted without a right ventricular (rv) lead and the device was not operating normally. The patient had a fragile right ventricle and the physician elected to implant a lead into the coronary sinus to pace only in the left ventricle (lv). The crt-p auto lead detect algorithm was attempting to measure rv lead impedance and due to the absence of a rv lead, the device was labeling the pulses delivered by the algorithm as premature ventricular contractions (pvcs). The labeled pvcs were causing lv pacing inhibition. Technical services discussed that crt-p devices are not designed to be implanted without a rv lead and suggested further intervention to connect a lv lead to the rv port and then plug the lv port, if that is the physician's desire. This would allow normal crt-p operation. The patient remained hospitalized, pending additional intervention. It was additionally reported that the patient experienced no adverse effects and it was planned to continue to monitor the situation.
 
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Brand NameVISIONIST X4 CRT-P
Type of DeviceIMPLANTABLE DEVICE
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 Key14291133
MDR Text Key290963519
Report Number2124215-2022-14334
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number768733
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/05/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/05/2022 Patient Sequence Number: 1
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