Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SAFIO S 53; PACING LEAD
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOTRONIK SE & CO. KG SAFIO S 53; PACING LEAD Back to Search Results
Model Number 370945
Medical Device Problem Codes Failure to Capture (1081); High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/24/2019
Type of Reportable Event Malfunction
Additional 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.
 
Event or Problem Description
It was reported that approx.58 months after the implantation the lead was capped due to high pacing impedances, high thresholds and loss of capture.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SAFIO S 53
Common Device Name
PACING LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key9175405
Report Number1028232-2019-04443
Device Sequence Number14160706
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) 10/04/2019
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 Date10/31/2016
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 10/10/2019
Initial Report FDA Received Date10/10/2019
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;
-
-