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

Model Number 359529

Device Problem Failure to Interrogate (1332)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2016

Event Type  malfunction  

Event Description

Patients device was not able to be interrogated.Interrogation would start and pop-up message would appear stating device has been reset too many times.All interrogation methods were used but we couldn't interrogate the device.Ram dump was taken.Device remains implanted.On 12/27/2016 - the initial analysis from the manufacturer shows inconsistent memory content in a write protected memory area.

Manufacturer Narrative

We received your event description for the above mentioned device.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The analysis is thus based on the inspection of the quality documents associated with the manufacture of this particular device as well as the data returned for evaluation.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.The data returned for analysis were inspected.The inspection revealed that the device switched into the safety backup mode on (b)(6) 2016 as a result of the detection of invalid memory content in a write protected area.Several attempts to reset the device - by the device itself - were not successful triggering the warning message as mentioned in the complaint description.By design, the pacemaker performs self-checks and is equipped with the ability to detect and repair invalid memory content.However, in the case the device cannot correct the memory content the pacemaker switches into the safety backup mode to assure the patients safety.While in this safety program, the pacemaker is capable to deliver antibradycardia therapies.Upon interrogation a device status error message appears to notify the user.The activation of the safety backup mode does not indicate a material or manufacturing problem.In summary, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The available data revealed that the clinical observation resulted from an invalid memory content.The root cause for the invalid memory content was not determinable.However, external influences such as strong electromagnetic fields could be taken into consideration.

• Brand Name: EVIA DR-T
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6214108
• MDR Text Key: 63569824
• Report Number: 1028232-2016-05246
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 359529
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2013
• 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 Age: 95 YR