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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-75/49; LV LEAD

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BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP L-75/49; LV LEAD Back to Search Results
Model Number 408718
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 11/24/2020
Event Type  Injury  
Event Description
This system was explanted due to infection.Should additional information become available, this file will be updated.
 
Manufacturer Narrative
An infection was observed following the implantation of this biotronik device.The sterilization process was investigated.The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc., are within its specified ranges for each distributed device.Additionally an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process.Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In summary, the infection was not device related.
 
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Brand Name
SENTUS PROMRI OTW QP L-75/49
Type of Device
LV LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key11065637
MDR Text Key223408392
Report Number1028232-2020-05645
Device Sequence Number1
Product Code OJX
UDI-Device Identifier04035479148942
UDI-Public04035479148942
Combination Product (y/n)N
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2020
Device Model Number408718
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/16/2020
Initial Date FDA Received12/23/2020
Supplement Dates Manufacturer Received12/24/2020
Supplement Dates FDA Received12/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age60 YR
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