MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EDORA 8 HF-T QP; CRT-P

Model Number 407137

Device Problem High Capture Threshold (3266)

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

Event Date 12/08/2020

Event Type  malfunction  

Event Description

After the implantation, it was observed during a follow-up check that the measurement results on the rv channel showed a too high threshold.A lead revision was performed.As the threshold values were found to be still too high, it was decided to change the device.

Manufacturer Narrative

The pacemaker was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this pacemaker were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the pacemaker was interrogated and the memory content was analyzed indicating no anomalies.Next, the header of the device was analyzed.The set screws could be easily screwed in and out, there was no foreign material inside the header bores.All dimensions of the header bores were within the range requested by the standard specifications.Also, the spring elements of the pacemaker did not show any deviations.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 sensing test was performed.Thereby the pacemaker sensed the attached heart signals free of noise, proving the sensing functions to be as expected.There was no indication of a device malfunction.Additionally provided device data were evaluated thoroughly.The data documented right ventricular threshold measurement values between 1.4v and 1.6v, measured on (b)(6) 2020.Analysis of available iegms showed background noise in the right ventricle, which can become visible in the selected high level of signal amplification.Furthermore, based on the iegm it was noted that the evoked response after stimulation was very weak most likely resulting from cross-channel blanking after left ventricular pacing (lvp).In conclusion, the device is fully functional.The analysis did not show any deviations from the technical specifications.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: EDORA 8 HF-T QP
• Type of Device: CRT-P
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11087707
• MDR Text Key: 224252265
• Report Number: 1028232-2020-05601
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 04035479147563
• UDI-Public: 04035479147563
• Combination Product (y/n): N
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 407137
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization