MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP S-85; LEAD

Model Number	401180
Medical Device Problem Codes	High impedance (1291); Unstable Capture Threshold (3269)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that impedance is often high on this lead, greater than 3000 ohms, and the thresholds are not stable.
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 provided trend data, acquired between (b)(6) 2019 and (b)(6) 2020 recorded the pacing impedance around 700 ohms with multiple sudden increases above 3000 ohms as reported in the complaint description.Furthermore the sensing amplitude showed varying values from 3mv to 20mv.The analysis of the provided iegm freezes revealed artifacts on the lv channel, which led to oversensing.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: SENTUS PROMRI OTW QP S-85
• Common Device Name: LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10225194
• Report Number: 1028232-2020-02699
• Device Sequence Number: 19363232
• Product Code: OJX
• UDI-Device Identifier: 04035479138417
• UDI-Public: 04035479138417
• Combination Product (Y/N): N
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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: 07/31/2018
• Device Model Number: 401180
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 04/01/2021
• 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