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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
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BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP L-85/49; LV LEAD Back to Search Results
Model Number 408719
Device Problem Ambient Noise Problem (2877)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2023
Event Type  malfunction  
Event Description
Lead was explanted due to noise on lead.No adverse patient events were reported.Should additional information be received, this file will be update.
 
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 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 Key18148170
MDR Text Key328269826
Report Number1028232-2023-05841
Device Sequence Number1
Product Code OJX
UDI-Device Identifier04035479148959
UDI-Public(01)04035479148959(17)230131
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 Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2023
Device Model Number408719
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2021
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 Outcome(s) Hospitalization;
Patient Age68 YR
Patient SexFemale
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