MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG TILDA R 53 US; LEAD

Model Number	382889
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportedly, the patient had a history of minor atrial oversensing that was previously managed by decreasing the programmed atrial sensitivity.However, the stored episodes seen during the (b)(6) 2021 interrogation are reportedly worse than anything seen in the past.Provocative testing was performed and noise on the atrial egm was reproduced along with ventricular oversensing with the patient lying on her back while turning her head from side to side.The egm noise was not able to be reproduced via isometrics, valsalva, deep respiration or coughing.The post-v and post-r refractory periods were set out to 155ms and the v sensitivity value was decreased to 0.8mv.Following these adjustments, further ventricular oversensing was unable to be reproduced and the impact on inappropriate mode switch will be evaluated over time.
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 analysis of the available trend data showed a stable pacing impedance between 450ohms and 600ohms.No iegm episodes were available for analysis.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: TILDA R 53 US
• Common Device Name: LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11691219
• Report Number: 1028232-2021-01878
• Device Sequence Number: 14233522
• Product Code: NVN
• UDI-Device Identifier: 04035479143305
• UDI-Public: 04035479143305
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 09/30/2019
• Device Model Number: 382889
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1