ENTOVIS DR-T PROMRI

Report

Report Number: 1028232-2014-002623
Event Type: Malfunction
Date Received: July 29, 2014
Date of Event: June 10, 2014
Report Date: July 18, 2014
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: DXY
PMA / PMN Number: P950037
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

AFTER IT WAS RECEIVED, THE PACEMAKER FIRST UNDERWENT A STATUS INTERROGATION. THE BATTERY STATE "ERI" WAS DISPLAYED. THE MEMORY CONTENT OF THE IMPLANT WAS ANALYZED. AN INCREASED POWER CONSUMPTION WAS DOCUMENTED, WHICH CONTRIBUTED TO THE PREMATURE ACTIVATION OF THE BATTERY STATE "ERI." THE IMPLANT'S ABILITY TO PROVIDE THERAPY WAS TESTED. DUE TO THE LOW BATTERY VOLTAGE, THERE WAS NO OUTPUT SIGNAL. THE DEVICE WAS THEN OPENED. THE VISUAL ANALYSIS OF THE ELECTRONIC MODULE SHOWED NO ANOMALIES. THE BATTERY WAS DISCHARGED BUT NOT DEFECTIVE. DURING THE ANALYSIS, A DAMAGED INTEGRATED CIRCUIT WAS IDENTIFIED, WHICH CAUSED AN INCREASED POWER CONSUMPTION AND SUBSEQUENTLY LED TO THE CLINICAL OBSERVATION. THE MANUFACTURING PROCESS OF THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS SHOWED NO ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS HAD BEEN CARRIED OUT CORRECTLY, AND THE POWER CONSUMPTION OF THE PACEMAKER, IN PARTICULAR, WAS UNREMARKABLE. IN SUMMARY, THE CLINICAL OBSERVATION RESULTED FROM AN INCREASED CURRENT UPTAKE, WHICH WAS CAUSED BY A DAMAGED INTEGRATED CIRCUIT OF THE ELECTRONIC MODULE.

Description of Event or Problem · 1

OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 10 MONTHS, INCREASED POWER CONSUMPTION WAS REPORTED. THE DEVICE WAS EXPLANTED AND IS UNDERGOING ANALYSIS. NO WORSENING OF THE PATIENT'S HEALTH WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
440836	ENTOVIS DR-T PROMRI	PACEMAKER	DXY	BIOTRONIK SE & CO. KG	371992

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization