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

Model Number 365463

Device Problems Difficult to Interrogate (1331); Battery Problem (2885)

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

Event Date 06/20/2018

Event Type  malfunction  

Event Description

It was reported that approx.95 months after the implantation the device could not be interrogated.Reset was performed in cooperation with a biotronik representative.The device could be programmed and interrogated again, but it was in eri.A quick exchange was recommended.

Manufacturer Narrative

The pacemaker was returned for analysis and underwent a routine status interrogation after it had been received.During the interrogation, a notification message appeared on the programmer referring to the state of the battery.The device status was eri after approximately 95 months of operating time.In a next step, the charge drawn from the battery was checked.The battery depletion proved to be as expected.The memory content of the device was analyzed.The analysis indicates that the activation of the battery status eri on (b)(6) 2018 resulted from a temporarily slightly increased current uptake.No other irregularities were found.The cause of the occurred resets could not be determined because the information in the device memory did no longer exist due to the manual reset performed by the clinic.In a next step, the pacemakers capability to provide therapy was tested.The antibradycardic output signal matched the programmed values, and the signal sensing of the device was normal.The pacemaker showed specification-conforming behavior in regard to its device functions.The current uptake, in particular, was normal and as expected.In addition, the manufacturing process of this device was reviewed.The production documents did not show any anomalies.All manufacturing steps had been carried out correctly.A performed standard final electrical test documented proper device behavior.In summary, the analysis indicated a temporarily increased current uptake of the pacemaker, which then led to the battery status eri.The cause of the temporarily increased current uptake could, however not be determined.During the analysis, the pacemaker functioned normally, and the current uptake, in particular, was normal and as expected.The cause of the occurred resets and the respective message could not be determined based on the available data.There was no material defect or manufacturing error.

• Brand Name: ENTOVIS DR-T
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 7703113
• MDR Text Key: 114469008
• Report Number: 1028232-2018-02488
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

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: 365463
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1