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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW BP S-85

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BIOTRONIK SE & CO. KG SENTUS PROMRI OTW BP S-85 Back to Search Results
Model Number 401177
Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2020
Event Type  malfunction  
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.
 
Event Description
Lead dislodgement. Detected by loss of capture. Lead was explanted and replaced with implant of a mdt attain stability qp lead.
 
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Brand NameSENTUS PROMRI OTW BP S-85
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key10972120
MDR Text Key221243226
Report Number1028232-2020-05381
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeDE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2017
Device Model Number401177
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/08/2020 Patient Sequence Number: 1
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