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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); Pacing Problem (1439); Device Sensing Problem (2917)
Patient Problem Non specific EKG/ECG Changes (1817)
Event Date 06/24/2018
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient experienced a heart rate of 30 beats per minute (bpm) for 45 seconds. It was noted after the 45 seconds of pacing inhibition the patients rate returned to normal. There was noise on the right ventricular (rv) lead and left ventricular (lv) lead, however, it was not oversensed. The patient's rv lead is a non-boston scientific product. In addition, there was a small spike in pacing impedances on the rv and lv leads. Isometrics and pocket manipulation was performed and the noise was not recreated. Boston scientific technical services (ts) the lv lead is programmed to pace to the rv lead ring so there could be a possible ring electrode issue on the rv lead. The lv lead was reprogrammed. Subsequently, a revision procedure was performed. The crt-p and rv lead were explanted and replaced. The lv lead remains in service. No additional 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 Key8510885
MDR Text Key141811787
Report Number2124215-2019-05438
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 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/05/2019
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number719952
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2017
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: 04/12/2019 Patient Sequence Number: 1
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