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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U128
Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917)
Patient Problem Non specific EKG/ECG Changes (1817)
Event Date 02/03/2017
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high out-of-range pacing impedance of greater than 2,000 ohms on the non-boston scientific right ventricular (rv) lead that resulted in a lead safety switch (lss) to the unipolar configuration. There was noise on the rv channel prior to the lss. After the lss, there was noise and oversensing and potentially some pacing inhibition resulting in about 4 seconds of asystole. It could not be determined if the patient had an intrinsic rhythm at that time or if there was pacing inhibition and asystole. This product remains in service. No adverse patient effects were reported.
 
Event Description
This report is being filed to update evaluation coding.
 
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Brand NameVALITUDE 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
MDR Report Key8197292
MDR Text Key131478114
Report Number2124215-2018-62654
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/24/2018
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number715511
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2019
Is This a Reprocessed and Reused Single-Use Device? No

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