MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INVENTRA 7 HF-T DF-1 PROMRI; No Match

Model Number 393019

Device Problem High impedance (1291)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

It was reported that this icd was explanted due to high shock impedance approx.60 months after the implantation.No adverse patient events were reported.Should additional information be received, this file will be updated.

Manufacturer Narrative

The icd was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.The icd was interrogated, revealing the mos2 battery status, 129 charging cycles were recorded in the devices memory.The memory content of the icd was inspected.During the inspection, the clinical observation could be confirmed.Elevated shock impedance of up to > 150 ohms was documented in the shock holter for shocks delivered with reversed polarity on (b)(6) 2022.Besides that, the data showed no anomalies.The shock impedance measurement functions of the icd were thoroughly tested in normal and reverse polarity configuration using different temperature environments up to 50 degrees c.All measured impedances were normal and as expected.There was no indication of a malfunction.Furthermore, 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 normal and expected sensing and shock delivery.In particular, the specified energy level was reached and the shock impedance was as expected.In conclusion, the device was proven to be fully functional.Despite through analysis of the icd, the observed elevated shock impedances during shock delivery with reversed polarity was not reproducible.Analysis revealed no indication of a device malfunction.However, the information you provided has been entered into our quality system as a complaint and will be used to evaluate the device functionality throughout our organization and help to maintain and improve the performance of our devices.

• Brand Name: INVENTRA 7 HF-T DF-1 PROMRI
• Type of Device: No Match
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 16064617
• MDR Text Key: 306658860
• Report Number: 1028232-2022-06597
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

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: 07/31/2018
• Device Model Number: 393019
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2017
• 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