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

Model Number	370945
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
This ra lead was explanted due to dislodgement.
Additional Manufacturer Narrative
The lead was not returned for analysis.The report therefore refers only to the analysis of the pacemaker.After it was received, the pacemaker underwent a status interrogation, and the memory content was analyzed.The analysis of the memory content showed proper device behavior.In a next step, the pacemaker was visually inspected, and the connection system was examined.The screws and the spring elements of the lead connections were without defects.Leads inserted in a test could be contacted with easy passage, low ohm values, and reliably.The drill hole dimensions were all within the dimensions defined in the standard.The sealing system was found to be undamaged.The pacemakers capability to provide therapy was tested.The antibradycardic output signal matched the programmed values, and the signal sensing of the device was normal.The pacemaker showed a specification-conforming behavior in regard to its device functions.In summary, the device was without defects during the analysis and within specifications both regarding the connection system and the electronics.There was no material defect or manufacturing error.

• Brand Name: SAFIO S 53
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9566813
• Report Number: 1028232-2020-00117
• Device Sequence Number: 3043150
• 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: 2019
• 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): 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 370945
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 02/12/2020
• 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