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

Model Number	362706
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Approximately 7 days after implantation, a loss of capture on the ventricular channel was reported.This lead was explanted.No adverse patient events were reported.
Additional Manufacturer Narrative
The lead and the pacemaker were returned for analysis.Within the pacemaker analysis, the device was properly interrogated and the memory content was analyzed indicating no anomalies.The header of the device was analyzed.The set screw could be easily screwed in and out, there was no foreign material inside the header bore.All dimensions of the header bore were within the range requested by the standard specifications.The spring element of the pacemaker did not show any deviations.The ability of the device to deliver therapies was verified.The antibradycardia pacing pulses proved to be normal in amplitude and frequency as programmed.There was no indication of a device malfunction.An additional long term pacing test was initiated.During the test, each pacing pulse was recorded.The evaluation of these pacing pulses documented regular device behavior.There was no intermittent or permanent loss of output.In the course of analysis, no deviations were noted that may have contributed to the reported clinical observation.The lead proved to be without fault throughout its inspection.The manufacturing process for these devices was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.In conclusion, the lead and the pacemaker are fully functional.The analysis did not show any deviations from the technical specifications.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: SIELLO T 60
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8633778
• Report Number: 1028232-2019-02056
• Device Sequence Number: 1655603
• 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: 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): 04/29/2019

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: 01/31/2021
• Device Model Number: 362706
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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