MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SIELLO T 60; PACING LEAD

Model Number	362706
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Ous mdr - it was reported that approx.72 months after the implant the bipolar pacing impedance was out of range (greater than 2500 ohms).The device settings were changed to unipolar.Two weeks later the lead and the entire pacemaker system was explanted and replaced.The lead was destroyed during the extraction procedure.
Additional Manufacturer Narrative
As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The analysis is thus based on the inspection of the manufacturing documents of the device as well as on the provided data.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The available data included a pacing impedance test performed on the (b)(6) 2019 which showed that the right ventricular pacing impedance was in bipolar configuration greater than 2500ohms as reported in the complaint description.In unipolar configuration, the pacing impedance value was measured at 409ohms.The provided photos which were probably taken during the extraction procedure of the lead, showed a deformation of the lead body in the proximal region.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.An analysis of the lead itself would be necessary to determine the root cause.Should additional information or the device itself become available for analysis, the investigation will be updated.

• Brand Name: SIELLO T 60
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8597526
• Report Number: 1028232-2019-01914
• Device Sequence Number: 16692598
• Product Code: NVN
• UDI-Device Identifier: 04035479106263
• UDI-Public: 04035479106263
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 04/16/2019

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: 11/30/2014
• Device Model Number: 362706
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1