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

Model Number 408719

Device Problems Failure to Capture (1081); High impedance (1291); Loss of Threshold (1633); Ambient Noise Problem (2877)

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

Event Date 11/09/2020

Event Type  malfunction  

Event Description

High pacing impedance, unsuccessful lv threshold test, and noise were recorded on this lead.Lead currently remains implanted.Should additional information become available, this report will be updated.

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Manufacturer Narrative

On 18-jan-2023 it was reported that impedance was above 3000 and no capture in any pole.Lead remains implanted.The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Manufacturer Narrative

On (b)(6) 2023 it was reported that impedance was above 3000 and no capture in any pole.Lead remains implanted.(b)(6) 2023 the lead was explanted due to no sensing, no capture at max outputs, impedances out of range.The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Manufacturer Narrative

On (b)(6) 2023 it was reported that impedance was above 3000 and no capture in any pole.Lead remains implanted.(b)(6) 2023 the lead was explanted due to no sensing, no capture at max outputs, impedances out of range.(b)(6) 2023 high thresholds is added to complaint.Upon receipt, the lead under complaint was found cut 33.5 cm distal to the is4 connector pin.Both lead fragments were available and subjected to an extensive analysis.During the visual inspection, the ligature marks were noted 44.5 cm proximal to the lead tip.The lead body was circularly constricted in this region and the conductor coil was fractured.This damage can be considered the root cause for the clinical observation.Based on the characteristics, it is reasonable to assume that the damage occurred due to a tight suture.Furthermore extraction damages were noted such as cuts in the insulation and deformations of the lead body.Prior to the analysis of the device, 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.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• 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: 10820046
• MDR Text Key: 215901752
• Report Number: 1028232-2020-04888
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 04035479148959
• UDI-Public: (01)04035479148959(17)210930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 408719
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2019
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female