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 10/23/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received and analyzed.The battery status was bos and four charging cycles were documented.The memory content of the icd was inspected.The available iegms from episodes 70 to 528 show the presence of noise in the lv channel.The impedance trends confirmed sudden pacing impedance values above 3000 ohms in the lv channel on (b)(6) 2022 with lv1-to-lv2 configuration.The header of the icd was inspected in detail, revealing no anomalies.The set screws could be easily screwed in and out, there was no foreign material inside the header bores.The set screws showed screw marks on the bottom side indicating that they were tightened during the implantation.Test leads could be properly inserted and connected to the device header.There was no indication of a material or manufacturing problem.In a next step, a sensing test was performed and the device sensed the attached heart signals free of noise.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.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a correct sensing and shock delivery.In particular, the specified energy level was reached.Furthermore, the impedance measurement functions of the icd were analyzed and all values were normal.The clinical observation was not reproducible.In conclusion, the root cause of the clinical observation was not determinable.The icd proved to be fully functional.The impedance measurement functions showed no anomalies.There was no indication of an icd malfunction.

Event Description

High impedances were reported approximately 7 months after the implantation.The icd was replaced and provided for analysis.The lead remains implanted.No adverse patient events were reported.Should additional information be received, this file will be updated.

Manufacturer Narrative

Noise on the rv and lv channels were also reported.Lead still remains implanted.The device was received and analyzed.The battery status was bos and four charging cycles were documented.The memory content of the icd was inspected.The available iegms from episodes 70 to 528 show the presence of noise in the lv channel.The impedance trends confirmed sudden pacing impedance values > 3000 ohms in the lv channel on july 26th, 2022 with lv1 to lv2 configuration.The header of the icd was inspected in detail, revealing no anomalies.The set screws could be easily screwed in and out, there was no foreign material inside the header bores.The set screws showed screw marks on the bottom side indicating that they were tightened during the implantation.Test leads could be properly inserted and connected to the device header.There was no indication of a material or manufacturing problem.In a next step, a sensing test was performed and the device sensed the attached heart signals free of noise.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.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a correct sensing and shock delivery.In particular, the specified energy level was reached.Furthermore, the impedance measurement functions of the icd were analyzed and all values were normal.The clinical observation was not reproducible.In conclusion, the root cause of the clinical observation was not determinable.The icd proved to be fully functional.The impedance measurement functions showed no anomalies.There was no indication of an icd malfunction.

• 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: 16248931
• MDR Text Key: 308201396
• Report Number: 1028232-2023-00417
• Device Sequence Number: 1
• Product Code: OJX
• 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: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 408719
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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