MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EVITY 8 DR-T; PACEMAKER

Model Number 407146

Device Problem High Capture Threshold (3266)

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

Event Date 08/31/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, a lead removal procedure was performed due to an elevated threshold.This device was also removed.No adverse patient events were reported.Should additional information be received, this file will be updated.

Manufacturer Narrative

The pacemaker and the lead were returned for analysis.Upon receipt, the pacemaker was interrogated properly, and the pacemakers memory content was analyzed indicating no anomalies.However, the ventricular threshold increased from 0.6v up to 3v between july 21, 2022 and august 31, 2022.The battery was found to be fully charged.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 is-1 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.An additional long-term pacing test was initiated.During the test, each pacing pulse was recorded.The evaluation of these pacing pulses documented regular device behavior.No intermittent or permanent loss of output was present.Upon receipt, the lead under complaint was subjected to an extensive analysis.The performance of the lead was scrutinized, including a visual, mechanical and electrical inspection.The analysis of the lead did not show any deviations from the technical specifications that might have contributed to the clinical observations.The quality documents accompanying the manufacturing process for the pacemaker and the lead were re-investigated.All production steps were performed accordingly, and in particular the final acceptance tests proved the devices functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: EVITY 8 DR-T
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15358820
• MDR Text Key: 299406184
• Report Number: 1028232-2022-04557
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• PMA/PMN Number: P950037
• 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: 09/02/2022

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: 09/30/2023
• Device Model Number: 407146
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/05/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2022
• 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