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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ETRINSA 8 HF-T PACEMAKER

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BIOTRONIK SE & CO. KG ETRINSA 8 HF-T PACEMAKER Back to Search Results
Model Number 394919
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 10/04/2017
Event Type  Injury  
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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
This pacemaker system was explanted due to infection. A new system was placed on the right side on (b)(6) 2017. Should additional information become available this file will be updated.
 
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Brand NameETRINSA 8 HF-T
Type of DevicePACEMAKER
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin D-123 59
GM D-12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key6990097
MDR Text Key113527857
Report Number1028232-2017-03866
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P950037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number394919
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2015
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: 10/31/2017 Patient Sequence Number: 1
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