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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 Failure to Capture (1081); Over-Sensing (1438)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/04/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn based on the available device data.There was no indication of a device malfunction.The file is closed.The investigation will be re-opened should additional data or device itself become available.
 
Event or Problem Description
It was reported that 59 months after the implant of this system oversensing on ventricular and atrial channels and loss of capture were noted.The pacemaker and the leads remain implanted.
 
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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 Key9235425
Report Number1028232-2019-04660
Device Sequence Number10865504
Product Code NVN
UDI-Device Identifier04035479113940
UDI-Public04035479113940
Combination Product (Y/N)N
PMA/510(K) Number
P950037
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/07/2019
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 Date08/31/2016
Device Model Number370945
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/24/2019
Initial Report FDA Received Date10/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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