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

Model Number 359529

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

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 returned data were inspected.Upon inspection of the data the clinical observation was confirmed.The remaining battery capacity is 15% and the eri estimation is less than 1 month.Further analysis of the data revealed that the clinical observation resulted from a temporarily elevated current consumption.The root cause of this observation could not be determined based on the information available for analysis.However, the data did not reveal any indication of a pacemaker malfunction.In summary, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned device data confirmed the battery status of 15% remaining capacity, which resulted from a temporarily elevated current consumption.Based on the information available for analysis the root cause of this observation could not be determined, however, there was no indication of a pacemaker malfunction.Should the device itself become available for analysis, this investigation will be updated.

Event Description

Ous mdr - it was reported that approx.79 months after the implantation a battery depletion with a remaining battery capacity 1 month and less than 15% was noted.The pacemaker was not returned to biotronik and no explant date was provided.No adverse patient side effects have been reported.

Manufacturer Narrative

The device was received and analyzed.Prior to the analysis of the device, the manufacturing process for this pacemaker 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.At a next step the returned data were inspected.Upon inspection of the data the clinical observation was confirmed.Further analysis of the data revealed that the clinical observation resulted from a temporarily elevated current consumption.The root cause of this observation could not be determined based on the information available for analysis.However, the data did not reveal any indication of a pacemaker malfunction.At a next step the pacemaker was subjected to an electrical analysis.The device interrogation revealed the battery status eri.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.The pacemaker functioned as expected showing no anomalies.In summary, the device proved to be fully functional during analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis revealed a temporarily slightly elevated current consumption leading to the clinical observation.Based on the information available for analysis the root cause of this observation could not be determined, however, there was no indication of a pacemaker malfunction.

• 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: 6215409
• MDR Text Key: 63626174
• Report Number: 1028232-2016-05040
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

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: 12/07/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2009
• 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