MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SAFIO S 60; PACING LEAD

Model Number	370946
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020, a patient was implanted with a new pacemaker.However, during follow-up before discharge on (b)(6), it was noted that the ra and rv leads were dislodged.On (b)(6), the doctor performed lead re-positioning surgery for the patient, but the leads dislodged again and could not be fixed.The doctor implanted 2 new leads for the patient.
Additional Manufacturer Narrative
Safio s (b)(4): upon receipt, the lead was capped 47 cm proximal to the is-1 connector pin.Only the distal fragment was received for analysis.The proximal part was missing.The analysis revealed several cuts into the insulation, which most likely resulted from the extraction procedure.A thorough analysis of the lead did not show any deviations which might have led to the reported dislodgement.Safio s (b)(4):: upon receipt, the lead under complaint was subjected to an extensive analysis.The analysis revealed a cut into the insulation (approx.27 cm distal to the is-1 connector pin), which most likely resulted from the extraction procedure.A thorough analysis of the lead did not show any deviations which might have led to the reported dislodgement.The manufacturing process for both leads was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: SAFIO S 60
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10175541
• Report Number: 1028232-2020-02477
• Device Sequence Number: 3574140
• Product Code: NVN
• UDI-Device Identifier: 04035479113957
• UDI-Public: 04035479113957
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2020

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: 07/31/2020
• Device Model Number: 370946
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 12/03/2020
• 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