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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U228
Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2022
Event Type  malfunction  
Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted. The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to b5 for more information regarding the specific circumstances of this event. Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring. A design enhancement was implemented in (b)(6) 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
 
Event Description
It was reported that at a previous follow-up appointment in (b)(6) 2021, high and out-of-range pacing impedance measurements (>3000 ohms) were noted from the right ventricular (rv) lead, which caused the device to declare a lead safety switch (lss). The lss resulted in over-sensed myopotential noisy signals causing pacing inhibition. At the most recent follow-up, high and variable rv impedance measurements were again observed. Additionally, the left ventricular (lv) pacing impedance measurements were out of range and the capture threshold measurement was high. Myopotential over-sensing was observed again. Boston scientific technical services (ts) was contacted and recommended thorough provocative maneuvers to evaluate both the rv lead integrity. The recommended maneuvers were performed, with no changes in impedance measurements nor over-sensed noisy signals. Ts was contacted again and it was discussed that the evidence does not point to rv lead fracture, but is more likely the result of fretting due to micromovement within the terminal pin in the header. Ts recommended re-programming the device to a split configuration to resolve the event. The rv lead is not a boston scientific product. At this time, the system remains implanted and no adverse patient effects were reported.
 
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Brand NameVISIONIST X4 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 Key14107636
MDR Text Key289260481
Report Number2124215-2022-10964
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/17/2017
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number705205
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2016
Is the Device Single Use? Yes
Type of Device Usage Initial

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