Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP L-85/49; LV LEAD
  • 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
 

BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP L-85/49; LV LEAD Back to Search Results
Model Number 408719
Device Problems Intermittent Capture (1080); High impedance (1291); Ambient Noise Problem (2877)
Event Date 03/01/2022
Event Type  malfunction  
Event Description
Lead has exhibited noise back in history.Recordings prior to (b)(6) 2021 follow up show many recordings with noise and some with loss of capture.Vectors were changed at last follow up in (b)(6) 2021.After that follow up, there are 5 home monitoring alerts for lv impedance greater than 3000 ohms.Lead remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.
 
Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SENTUS PROMRI OTW QP L-85/49
Type of Device
LV LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key13765096
MDR Text Key287203010
Report Number1028232-2022-01245
Device Sequence Number1
Product Code OJX
UDI-Device Identifier04035479148959
UDI-Public04035479148959
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Report Date 03/01/2022
1 Device was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2022
Device Model Number408719
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
-
-