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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-75; LV LEAD
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BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP L-75; LV LEAD Back to Search Results
Model Number 401182
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/14/2021
Type of Reportable Event Malfunction
Event or Problem Description
After an implantation period of approx.57 months, a lead fracture was observed by homemonitoring.The lead was explanted.
 
Additional 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-75
Common Device Name
LV LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key11819571
Report Number1028232-2021-02594
Device Sequence Number14389531
Product Code OJX
UDI-Device Identifier04035479138431
UDI-Public04035479138431
Combination Product (Y/N)N
PMA/510(K) Number
P070008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2021
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/23/2021
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
Operator of Device Health Professional
Device Expiration Date05/31/2018
Device Model Number401182
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/12/2021
Supplement Date Received by Manufacturer06/16/2021
Initial Report FDA Received Date05/13/2021
Supplement Report FDA Received Date06/17/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
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