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

Model Number	359529
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.79 months, it was reported that the device shows the eri status.The patient admitted for urgent device replacement.
Additional Manufacturer Narrative
The device was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon initial interrogation a warning message was triggered regarding the battery condition, confirming the clinical observation.The memory content of the device was inspected.The inspection revealed that the eri battery status was triggered on june 12, 2021.Furthermore, the battery holter documented a battery voltage drop on that day as well as an invalid memory content which was corrected automatically by the device.After automatic memory correction, the battery measurements showed no conspicuities.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 in eri mode.There was no indication of a device malfunction.During the further course of the analysis, the pacemaker was opened to inspect the inner assembly.The inspection of the electronic module did not show any anomalies.The battery was found to be sufficiently charged.However, the battery was sent to the manufacturer for further analysis.The manufacturing records of the battery were inspected, documenting that the battery parameters were within specification during the battery manufacturing.No anomalies were documented during the production process, associated with this battery.The following inspection of the battery did not reveal any signs of damage.The voltage measurement confirmed a sufficiently charged battery.There was no indication of a battery failure.In conclusion, a battery failure could not be confirmed during analysis.The documented battery voltage drop as well as the eri battery status activation on june 12, 2021 can be attributed to an invalid memory content resulting in an erroneous battery measurement.The root cause for the invalid memory content was not determinable.However, external influences such as electromagnetic interferences could be taken into consideration.

• Brand Name: EVIA DR-T
• Common Device Name: 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: 13524611
• Report Number: 1028232-2022-00768
• Device Sequence Number: 5312168
• Product Code: NVZ
• UDI-Device Identifier: 04035479101312
• UDI-Public: 04035479101312
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 359529
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown