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

Model Number	362706
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.63 months, an increasing threshold was observed.The lead was capped and the pacemaker was explanted.
Additional Manufacturer Narrative
Codes remain the same as the initial report.The lead was not returned for analysis.Thus, the analysis report refers exclusively to the pacemaker.Prior to the pacemaker analysis, the quality documents accompanying the manufacturing process for the lead and the pacemaker were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the pacemaker was interrogated and the memory content was analyzed indicating no anomalies.The eri battery status could not be confirmed.The battery status was found to be greater than 75 percent.Furthermore, impedance measurements documented a trend towards lower bipolar lead impedances since 2017.The threshold test from (b)(6) 2021 documented a measured threshold of 3.8v, confirming the clinical observation.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.Also, the spring element of the pacemaker did not show any deviations.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and 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 conclusion, the device is 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: 11729604
• Report Number: 1028232-2021-02028
• Device Sequence Number: 3946588
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 10/31/2017
• Device Model Number: 362706
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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: Hospitalization