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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SAFIO S 60; PACING LEAD
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BIOTRONIK SE & CO. KG SAFIO S 60; PACING LEAD Back to Search Results
Model Number 370946
Medical Device Problem Code High Capture Threshold (3266)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/10/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lead 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.
 
Event or Problem Description
It was reported that an increasing pacing threshold was observed approx.58 months after implantation.The lead was capped and left in situ.A new lead was implanted.
 
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Brand Name
SAFIO S 60
Common Device Name
PACING LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
DE  12359
MDR Report Key10287081
Report Number1028232-2020-02959
Device Sequence Number10977713
Product Code NVN
UDI-Device Identifier04035479113957
UDI-Public04035479113957
Combination Product (Y/N)N
Initial Reporter CountryDE
PMA/510(K) Number
P950037
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/09/2020
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 Date09/30/2016
Device Model Number370946
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/15/2020
Initial Report FDA Received Date07/16/2020
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;
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