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

Model Number 359529

Device Problems Failure to Capture (1081); Premature Elective Replacement Indicator (1483)

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

Event Date 11/30/2016

Event Type  malfunction  

Event Description

Ous mdr - after an implantation period of approx.50 months, it was reported that the device indicated eri, whereas a last follow-up in (b)(6) 2016 showed a remaining battery longevity > 8 years.Furthermore loss of capture was reported.The device was replaced and returned to biotronik for analysis.No adverse patient side effects have been reported.

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 reinvestigated.All production steps had been performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon initial interrogation a warning message was triggered regarding the battery condition.The memory content of the device was inspected.The inspection revealed that the battery voltage decreased faster than expected.However the current consumption was normal.At a next step the ability of the device to deliver therapies was verified.As a result of a depleted battery the therapy functionality of the pacemaker was not available.Therefore subsequently the pacemaker was opened and subjected to further investigation.The visual inspection of the inner assembly showed no anomalies but the battery was found to be depleted.The battery was disconnected from the electronic module.Further thorough investigation of the electronic module did not show any abnormality.In particular the current consumption proved to be normal and expected.At a next step the battery was sent to the manufacturer for analysis.The battery was subjected to a visual and an electrical inspection, including xray as well as microcalorimetry analysis and confirmed the battery depletion.The destructive analysis revealed that an internal short circuit within the battery contributed to an increased internal self depletion and thereby to the clinical observation.

• 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: 6214835
• MDR Text Key: 63611336
• Report Number: 1028232-2016-05164
• 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: 12/15/2016

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2010
• 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