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U.S. Department of Health and Human Services

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

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BIOTRONIK SE & CO. KG SENTUS OTW QP L-85; LV LEAD Back to Search Results
Model Number 386836
Device Problem Ambient Noise Problem (2877)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2022
Event Type  malfunction  
Event Description
Clinician reported noise on the lv channel in crt interrupt recordings transmitted to home monitoring.Patient has experienced phrenic nerve stimulation in the past and so lv vector reprogramming has been an ongoing challenge.Lead to be evaluated further and remains implanted.Should additional information be received, 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.
 
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Brand Name
SENTUS OTW QP L-85
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 Key14565356
MDR Text Key293086863
Report Number1028232-2022-02819
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070008
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,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient 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 Date09/30/2017
Device Model Number386836
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/26/2022
Initial Date FDA Received06/01/2022
Supplement Dates Manufacturer Received06/02/2022
Supplement Dates FDA Received06/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age79 YR
Patient SexMale
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