MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EVIA HF-T; CRT-P

Model Number 377208

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This device is at eri indication and replaced.Should additional information be received, this file will be updated.

Manufacturer Narrative

Upon receipt, the device interrogation revealed the battery status eri, which was triggered on (b)(6) 2015.At a first step the ability of the device to deliver therapies was verified.The antibradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.There was no indication of a device malfunction.The programmed parameters were inspected.It was noted, that the left ventricular pacing output was temporarily programmed to 4.0 v for 1.5 ms.This represents a high current program, draining the battery.The device was implanted for 32 months.Taking the high current program for crt pacing into account, the eri condition was found to be anticipated.In conclusion, the pacemaker was fully functional.The battery status was anticipated.Biotronik monitors the post-market performance of its products closely in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.For this reason we encourage close dialogue between clinicians and our product experts in order to explore all options to minimize any such occurrences in future.

• Brand Name: EVIA HF-T
• Type of Device: CRT-P
• 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: 5367356
• MDR Text Key: 35987168
• Report Number: 1028232-2016-00032
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 377208
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2012
• 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
• Patient Age: 87 YR