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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Endocarditis (1834); Unspecified Infection (1930); Staphylococcus Aureus (2058); No Code Available (3191); Pericardial Effusion (3271)
Event Date 11/06/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient experienced an infection and endocarditis. An echocardiogram was performed, and vegetation was seen on the leads. Subsequently, a revision procedure was performed. It was noted that during the beginning of the procedure there was a trace of a pericardial effusion, however, the pericardial space was monitored and there was no change during the entire procedure. The right ventricular (rv) lead fragmented during the removal process; however, the entire rv lead was successfully removed. The crt-p, left ventricular (lv) lead, non-boston scientific right atrial (ra) lead, and non-boston scientific rv lead were successfully explanted. No additional 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 CORPORATION
cashel road
clonmel
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key11234050
MDR Text Key228839273
Report Number2124215-2021-02315
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 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/15/2021
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number712757
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2019
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: 01/26/2021 Patient Sequence Number: 1
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