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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SAFIO S 53; PACING LEAD
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BIOTRONIK SE & CO. KG SAFIO S 53; PACING LEAD Back to Search Results
Model Number 370945
Medical Device Problem Codes Extracardiac stimulation (1463); Ambient Noise Problem (2877)
Health Effect - Clinical Code Undesired Nerve Stimulation (1980)
Date of Event 02/26/2021
Type of Reportable Event Malfunction
Event or Problem Description
This lead was capped and replaced due to bipolar lead failure, noise in bipolar programming, and pectoral stim in unipolar pacing configuration.No adverse patient events were reported.Should additional information become available, this file will be updated.
 
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
SAFIO S 53
Common Device Name
PACING LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key11449328
Report Number1028232-2021-01161
Device Sequence Number11716847
Product Code NVN
UDI-Device Identifier04035479113940
UDI-Public04035479113940
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P950037
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/26/2021
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 Model Number370945
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/26/2021
Supplement Date Received by Manufacturer03/11/2021
Initial Report FDA Received Date03/09/2021
Supplement Report FDA Received Date03/12/2021
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;
Patient Age57 YR
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