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

Model Number 365463

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 11/10/2014

Event Type  malfunction  

Event Description

Ous mdr - after an implantation time of about 31 months, the pacemaker showed a remaining capacity of 50% and a calculated eri in 4 years and 11 months.The device is currently still actively implanted.No deterioration of the patient's state of health was reported.

Manufacturer Narrative

The device was not returned for analysis.The analysis is therefore based on the available production documents and the returned device data.The manufacturing process of this device was reviewed.The production documents did not show any anomalies that could be related to the complaint.All manufacturing steps had been carried out correctly.The returned device data were thoroughly analyzed.The clinical observation was confirmed.The analysis of the pacemaker memory excerpt documented unexpected power consumption.This could indicate a dysfunction of the pacemaker electronics.If the current power consumption should remain constant, which can, however, not be predicted based on the available data, a remaining operating time of less than 24 months can be expected.The implant was not returned for analysis.The review of the production history did not provide any indication of a material defect or manufacturing error.However, the analysis of the provided device data showed unexpected power consumption of the implant.To determine the cause of the increased power consumption, it is necessary to return the pacemaker.

Manufacturer Narrative

After it was received, the pacemaker first underwent a status interrogation, and the memory content of the implant was analyzed.The analysis of the memory content showed an increased current uptake of the device.In general, the programmer displays a warning message to the user in case of increased current uptake.The pacemaker's capability to provide therapy was tested.The anti-bradycardic output signal matched the programmed values, and the signal sensing of the device was normal.The pacemaker showed behavior according to specification in regard to its device functions.In a next step, the pacemaker was opened, and the components of the electronic module were inspected.The battery was still sufficiently charged.Further analysis identified a damaged capacitor that caused an increased power consumption and then led to the clinical observation.The component was removed from the electronic module, and the current uptake then proved to be as expected.There are no other causes for the increased current uptake than the damaged capacitor.In addition, the manufacturing process of this device was reviewed.The production documents did not show any anomalies that could be related to the complaint.All manufacturing steps had been carried out correctly, and the power consumption of the pacemaker, in particular, was unremarkable.In summary, the clinical observation resulted from an increased current uptake, which was caused by a damaged capacitor of the electronic module.The check of the production history showed that the device functioned properly at the time of shipment.

• 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
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 4332956
• MDR Text Key: 5146283
• Report Number: 1028232-2014-006042
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

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: 365463
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 12/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2012
• 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