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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 Under-Sensing (1661)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/05/2020
Type of Reportable Event Malfunction
Event or Problem Description
After an implantation period of approx.67 months, ventricular undersensing was reported.The lead was explanted and replaced.
 
Additional Manufacturer Narrative
The returned lead was thoroughly analyzed.During the analysis, the lead was checked visually, electrically, and mechanically.The analysis found insulation abrasion between 4 and 3 cm proximal of the tip electrode.This damage is with high probability the cause of the clinical complaint.The observed damage manifestation leads to the assumption of friction against a neighboring partner lead.X-ray images or diagnostic images of any other kind, which could provide information on the positional relationships of the implanted system in the body, were not available for analysis.The manufacturing process of this lead was reviewed.The production documents showed no anomalies.All manufacturing steps had been carried out correctly.In summary, there were no indications of a material defect or manufacturing error.
 
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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
MDR Report Key10897633
Report Number1028232-2020-05137
Device Sequence Number3284921
Product Code NVN
UDI-Device Identifier04035479113957
UDI-Public04035479113957
Combination Product (Y/N)N
PMA/510(K) Number
P950037
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/12/2020
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 Date12/31/2016
Device Model Number370946
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2020
Initial Date Received by Manufacturer 11/24/2020
Supplement Date Received by Manufacturer03/09/2021
Initial Report FDA Received Date11/24/2020
Supplement Report FDA Received Date03/15/2021
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;
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