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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG AMVIA EDGE DR-T; PACEMAKER

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BIOTRONIK SE & CO. KG AMVIA EDGE DR-T; PACEMAKER Back to Search Results
Model Number 460163
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/20/2023
Event Type  Injury  
Event Description
Pacemaker system discarded due to patient bleeding issues during implant.Unable to reimplant after bleeding was controlled.Should additional information be received, this file will be updated.
 
Manufacturer Narrative
The device 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
AMVIA EDGE DR-T
Type of Device
PACEMAKER
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key18032646
MDR Text Key326906422
Report Number1028232-2023-05523
Device Sequence Number1
Product Code NVZ
UDI-Device Identifier04035479173999
UDI-Public(01)04035479173999(17)241231
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/31/2023
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 Model Number460163
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/23/2023
Initial Date FDA Received10/30/2023
Supplement Dates Manufacturer Received10/31/2023
Supplement Dates FDA Received10/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age67 YR
Patient SexFemale
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