MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SAFIO S 53; PACING LEAD

Model Number	370945
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lead 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.
Event or Problem Description
Ous mdr - this ra lead had no capture at max output and impedances of greater than 2500 ohms.This lead was explanted on (b)(6) 2019.
Event or Problem Description
Ous mdr - this ra lead had no capture at max output and impedances of greater than 2500 ohms.This lead was explanted on (b)(6) 2019.

• Brand Name: SAFIO S 53
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8496928
• Report Number: 1028232-2019-01404
• Device Sequence Number: 16409670
• Product Code: NVN
• UDI-Device Identifier: 04035479113940
• UDI-Public: 04035479113940
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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 Date: 09/30/2015
• Device Model Number: 370945
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization