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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 Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877); Device Sensing Problem (2917)
Patient Problem Dizziness (2194)
Event Date 08/24/2018
Event Type  Injury  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
 
Event Description
Boston scientific received information that the patient presented to the emergency room with complaints of lightheadedness. Upon interrogation oversensing of the minute ventilation signal was seen on the right ventricular (rv) channel. The oversensing led to pacing inhibition with asystole between five to eight seconds. Subsequently the rate response trend feature was programmed off in the cardiac resynchronization therapy pacemaker (crt-p). The crt-p and another manufacturer's rv lead remain in service and no additional adverse patient effects were reported.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
 
Event Description
It was reported that another manufacturer's right ventricular (rv) lead was surgically abandoned due to the high out of range pacing impedance measurements and oversensing of noise that led to pacing inhibition with asystole greater than two seconds. A new rv lead was successfully implanted. The cardiac resynchronization therapy pacemaker (crt-p) remains in service and 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 Key7983926
MDR Text Key124298308
Report Number2124215-2018-18281
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
Report Date 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/12/2017
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number100573
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/19/2018 Patient Sequence Number: 1
Treatment
4542; H120; MISMATCH; U125
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