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

Model Number 460160

Device Problem Telemetry Discrepancy (1629)

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

Event Date 11/17/2023

Event Type  malfunction  

Event Description

This device was explanted due to a telemetry error during interrogation.No adverse patient events were reported.Should additional information be received, this file will be update.

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 reviewed.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.Upon receipt, the observation could be confirmed.The interrogation attempt led an unexpected programmer shutdown.After removing the unicode characters from the lead serial number field using analysis equipment, the device interrogation was successfully performed.In a next step, 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 addition, the impedance measurement functions and the magnet response behavior of the device were thoroughly tested.There was no indication of a pacemaker malfunction.Psw 2302.N and psw 2401.N the unexpected shutdown occurs under special circumstances, if japanese was selected as the language setting for the programmer during the previous follow-up, and full size letters (unicode) were entered in the lead serial number field on the patient information of the implantable device.In this particular case, the lead serial number started with 2 digits from half size letter and used full size letter to complete the serial number.The event is caused by insufficient string length checking if specific unicode characters are entered with the japanese language setting for the lead serial number, allowing a truncation of the string sent to the amvia sky.If such a truncated string is interrogated, the programmer will shut down unexpectedly and the pacemaker cannot be interrogated or reprogrammed.The robustness of unicode string length checking and processing has been enhanced within quality improvements of psw 2402.N.Furthermore, as of psw 2402.N the lead serial number can only be entered with the non-unicode keyboard.

• Brand Name: AMVIA SKY 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: 18177831
• MDR Text Key: 328627962
• Report Number: 1028232-2023-05929
• 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: 01/02/2024

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 Model Number: 460160
• 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: 11/20/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2023
• 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