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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 02/01/2019
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) declared a lead safety switch (lss) due to high out-of-range (oor) pacing impedances on the right ventricular (rv) lead, measuring greater than 2000 ohms. After the lss, noise and oversensing occurred, which resulted in pacing inhibition. The patient experienced greater than 2 seconds of asystole. The patient's rv lead was a non-boston scientific product. Troubleshooting was performed and the noise was reproduced with isometrics in the unipolar but not in the bipolar configuration. The lss feature was programmed off and the rv lead was reprogrammed to bipolar. Subsequently, another oor impedance alert occurred. Boston scientific technical services (ts) discussed the impedance spikes could be due to intermittent ring contact in the head. Ts recommended reprogramming to bipolar sense and unipolar pace. This crt-p remains in service. No adverse patient effects were reported.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CLONMEL LIMITED
cashel road
,
clonmel
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
,
saint paul, MN 55112
6515826168
MDR Report Key8546038
MDR Text Key142956332
Report Number2124215-2019-07563
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/08/2018
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number714936
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 Received06/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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