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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) Back to Search Results
Model Number U225
Device Problems Signal Artifact/Noise (1036); Low impedance (2285)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2020
Event Type  malfunction  
Event Description
It was reported that the health care professional requested technical services to reach out to the patient. The patient was reached and a red call doctor (rcd) icon and yellow sending waves were noted in the latitude communicator. Upon further review of the latitude information, it was noted that the right atrial (ra) and right ventricular (rv) leads both exhibited low out of range pacing impedance. The ra and rv leads are non-boston scientific products. There is no information available at this time regarding the cause of the impedance issue. The device system remains in service at this time. No adverse patient effects were reported. Further information was requested. Additional information received indicates the reason of the rcd icon is that the patient received a new communicator. Reportedly, the patient's last follow up was performed on (b)(6) 2021, in which noise was noted for the rv and left ventricular (lv) leads, both have unipolar configurations and no consequences to the patient were noted. The lv lead is also a non-boston scientific product. The patient will continue with the scheduled follow ups as determined by the clinic.
 
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Brand NameVISIONIST CRT-P
Type of DeviceCARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (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 Key12625716
MDR Text Key276204539
Report Number2124215-2021-28040
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2018
Device Model NumberU225
Device Catalogue NumberU225
Device Lot Number702292
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 Received08/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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