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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) Back to Search Results
Model Number U125
Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917); High Capture Threshold (3266)
Patient Problems Non specific EKG/ECG Changes (1817); Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
Event Date 04/15/2018
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited jumpy impedance measurements on both the non-boston scientific right ventricular (rv) and left ventricular (lv) leads. The impedances varied between 450 ohms and 1,250 ohms, still within the normal range. Subsequently, the impedance on both leads steadily increased to around 1,600 ohms. The rv and lv leads also exhibited noise, oversensing, and loss of capture (loc). The oversensing resulted in some pacing inhibition. The cause of the clinical observations could not be determined but a spring contact issue between the leads and header was suspected. The rv lead was reprogrammed to unipolar pacing and the lv lead was programmed to pace/sense from ring to can. It was also noted that there were two spikes in impedance on the non-boston scientific right atrial (ra) lead. The impedance spikes were high and out-of-range, greater than 2,000 ohms. Subsequently, the ra impedance has been stable and within range. This product remains in service. No adverse patient effects were reported.
 
Event Description
This report is being filed because an updated conclusion code was provided based on trend analysis.
 
Event Description
Additional information was received that another episode with noise occurred on this cardiac resynchronization therapy pacemaker (crt-p) system. The patient also reported being symptomatic. The noise resulted in oversensing and pacing inhibition that caused about a 3 second pause. Boston scientific technical services (ts) reviewed all of the available data and suggested that this may be a lead integrity issue; however, no further action was taken to determine cause at this time. The physician elected to continue monitoring. The crt-p was reprogrammed to ddd mode and the right ventricular (rv) sensitivity was lowered. This product remains in service. No adverse patient effects were reported.
 
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Brand NameVALITUDE 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 CLONMEL LIMITED
cashel road
,
clonmel
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
,
saint paul, MN 55112
6515826168
MDR Report Key8016351
MDR Text Key125438207
Report Number2124215-2018-60624
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/12/2019
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number705981
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 Received11/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2017
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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