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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 Failure to Read Input Signal (1581); Low impedance (2285)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2020
Event Type  malfunction  
Manufacturer Narrative
The local area field representative was contacted for additional information. At this time, no further information is available. This investigation will be updated should further information be provided.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) triggered a lead safety switch (lss) due to low out-of-range right ventricular (rv) pace impedance measurements less than 200 ohms. In addition, low amplitude waves were observed. It was also noted that brady mode had been programmed off. This device remains in service. No adverse patient effects were reported.
 
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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 Key10636813
MDR Text Key210049688
Report Number2124215-2020-19706
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/16/2020
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number709427
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 Received08/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2018
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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