MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EVITY 6 DR-T; PACEMAKER

Model Number	407149
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Before implant, the pacemaker was interrogated, presenting error message and being asked to be reinitialized.Reinitialization was performed but resulted unsuccessful, since the pacemaker continues with the error message.
Additional Manufacturer Narrative
The pacemaker 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.Upon receipt, the pacemaker was subjected to an electrical incoming inspection.During initial interrogation a warning message was displayed on the programmer indicating invalid memory content.This observation was confirmed by an analysis of the memory content.In general, the pacemaker is equipped with the ability to detect and repair invalid memory content.If the invalid memory content cannot be corrected automatically, by design the pacemaker will activate the safety backup mode to ensure patient safety.While in this safety program, the pacemaker is capable to deliver anti-bradycardia therapies.Upon interrogation a device status error message appears to notify the user.Next, a detailed investigation of the memory content of the device was performed.Thereby, recurrent invalid memory content in the same memory area was found, leading to the automatic activation of the safety backup mode for several times.Further analysis on the electronic module revealed a damaged integrated circuit to be causal for the clinical observation.In summary, the clinical observation was confirmed, the device was found being in the safety backup mode.Further detailed analysis identified a damaged integrated circuit which was causal for the clinical observation.

• Brand Name: EVITY 6 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: 12868544
• Report Number: 1028232-2021-06409
• Device Sequence Number: 3643849
• Product Code: NVZ
• UDI-Device Identifier: 04035479147686
• UDI-Public: 04035479147686
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 02/28/2022
• Device Model Number: 407149
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown