• Decrease font size
  • Return font size to normal
  • Increase font size
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)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U125
Device Problems Signal Artifact/Noise (1036); Premature Discharge of Battery (1057); High impedance (1291)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/11/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information is being requested from the field. If additional information is received this report will be updated.
 
Event Description
It was reported that the health care professional (hcp) questioned premature battery depletion (pbd) on this cardiac resynchronization therapy pacemaker (crt-p). Device data was preserved and submitted for boston scientific engineering review. Engineering analysis showed a previously triggered lead safety switch (lss) due to a spike in a pace impedance measurement of greater than 3000 ohms on this non boston scientific left ventricular (lv) lead. This had caused a slight increase in power consumption, yet the device appeared to be functioning properly based on the settings and operating conditions. This was noted to be expected usage based on the programmed settings and therapy used. The device remains in service. No adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 MN
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key10638212
MDR Text Key210513592
Report Number2124215-2020-18801
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,Followup
Report Date 12/19/2020
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 Date08/08/2019
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number706688
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-