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

Model Number 371998

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 05/17/2016

Event Type  malfunction  

Event Description

Ous mdr - after an implantation time of about 44 months, it was reported that the device had a remaining battery capacity of 25% with eri expected in 1 year and 11 months.The device was explanted on (b)(6) 2016 and returned to biotronik for analysis.No deterioration of the patients state of health was reported.

Manufacturer Narrative

The pacemaker first underwent a status interrogation, and the device memory was analyzed.The device status had been eri since (b)(6) 2016.The charge drawn from the battery was checked.The check indicated an unexpected battery discharge.The pacemakers 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 specification-conforming behavior in regard to its device functions.The pacemaker was then opened.The visual inspection of the internal structure did not show any irregularities.The battery voltage was measured.The measurement confirmed an unexpected battery discharge.The battery was returned to the battery manufacturer for a thorough analysis.First, a microcalorimetric measurement of the battery was performed.This showed an increased heat tone.In a next step, the battery was opened and examined.An increased battery-internal self-discharge was confirmed, which contributed to the premature battery depletion.In summary, premature battery depletion was confirmed during the analysis of the pacemaker.The clinical observation resulted from an increased self-discharge of the battery.The electronic module proved to be without defects during the analysis.Based on the analysis, all therapy functions critical for the patient safety were fully available during the implantation time.

• Brand Name: EVIA SR-T PROMRI
• 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: 6215411
• MDR Text Key: 63624544
• Report Number: 1028232-2016-05062
• 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: 12/08/2016

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: 371998
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2011
• 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