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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP S-85/49; LV LEAD
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BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP S-85/49; LV LEAD Back to Search Results
Model Number 406082
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2024
Event Type  malfunction  
Event Description
The lead dislodged after the implant.The lead will be repositioned.No data available for analysis.Should additional information be received, this file will be updated.
 
Manufacturer Narrative
The lead is currently not available for analysis.No conclusion can be drawn based on available information 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 S-85/49
Type of Device
LV LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
DE  12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key18800114
MDR Text Key336794336
Report Number1028232-2024-01113
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeDE
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number406082
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/28/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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