MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP L-85/49; LV LEAD

Model Number 408719

Device Problems High impedance (1291); Ambient Noise Problem (2877)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2021

Event Type  malfunction  

Event Description

It can be observed the evidence of the presence of noise in lv channel during evocative maneuvers.Moreover, it can be observed in stimulation impedance trend frequently peaks above 3000 ohm.The physician, after an hospital fu ((b)(6) 2021), decided to switch from biv stimulation to rv stimulation only and to plan a lead revision in the next days.

Manufacturer Narrative

This lv lead was explanted and replaced on (b)(6) 2022.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 quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.The analysis of the provided trend data, acquired between 18th april 2021 and 13th december 2021 showed the sudden increased pacing impedance from approximately 1000 ohms to greater than 3000 ohms at the end of the recorded period.The analysis of the provided iegm episodes revealed artifacts on the lv channel, which led to the reported 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 L-85/49
• Type of Device: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 13014745
• MDR Text Key: 282344055
• Report Number: 1028232-2021-06781
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 04035479148959
• UDI-Public: 04035479148959
• Combination Product (y/n): N
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 408719
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 03/04/2022
• Supplement Dates FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1