MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SELOX ST 60; PACING LEAD

Model Number	346367
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient passed away for unknown reasons approx.36 months after the pacemaker implantation.The pacemaker was already reported on the (b)(6) 2021.With the product arrival on the (b)(6) 2021 also the two implanted leads were received.
Additional Manufacturer Narrative
Upon receipt, the lead was found cut through.Only the proximal part of the lead was returned for analysis.The returned fragment was visually examined.It is likely that the lead was cut during extraction.Apart from the present fragmentation no damage was observed.Due to the fragmented state of the lead electrical analysis was limited to the dc resistances of the lead fragments.No peculiarities were found.The analysis did not reveal any sign of a material or manufacturing problem.The manufacturing process for this lead was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.

• Brand Name: SELOX ST 60
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12139999
• Report Number: 1028232-2021-03866
• Device Sequence Number: 11775261
• Product Code: NVN
• UDI-Device Identifier: 04035479077853
• UDI-Public: 04035479077853
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2011
• Device Model Number: 346367
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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: Death