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 05/25/2016

Event Type  malfunction  

Event Description

This device was at eri indication and replaced with an oem device.Should additional information be received, this file will be updated.

Manufacturer Narrative

The pacemaker was returned and analyzed.The memory content demonstrated a normal functionality of the device while implanted and in service.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.There was no indication of a device malfunction.In agreement with the clinical observation, the device interrogation revealed the battery status eri.The archive data and the programmed parameters were inspected.High left ventricular pacing outputs of 5.6 v and 1.5 ms were documented in the archive data.This represents a high current program, which results in a faster discharge of the battery.The amount of charge taken from the battery was verified and the battery condition was found to be as expected.In conclusion, the pacemaker was fully functional.The battery status was anticipated.

• 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: 5781932
• MDR Text Key: 49148231
• Report Number: 1028232-2016-02471
• 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: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2012
• 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: 70 YR