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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U125
Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pocket Erosion (2013); No Code Available (3191)
Event Date 08/19/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued. (b)(4).
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was part of a system revision due to infection, erosion and contamination issues. The patient was treated with intravenous antibiotics. Additional information indicates that the origin of the contamination was determined as the pulse generator eroded out of patient's skin and pocket. Therefore, the system needed to be removed for infection. The field representative also confirmed that the device contributed to the contamination as it leads to the erosion through the skin. There were no additional adverse patient effects reported. The crt-p was explanted.
 
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Brand NameVALITUDE 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 CORPORATION
cashel road
clonmel
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key10791293
MDR Text Key214749152
Report Number2124215-2020-23877
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
Type of Report Initial
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/30/2019
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number706894
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 Received08/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/13/2017
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: 11/05/2020 Patient Sequence Number: 1
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