FDA Adverse Event Malfunction Summary report: N

KAIROS DR

MDR report key: 1062201 · Received June 13, 2008

Report

Report Number: 1028232-2008-00634
Event Type: Malfunction
Date Received: June 13, 2008
Date of Event: October 30, 2007
Report Date: May 14, 2008
Manufacturer: BIOTRONIK GMBH AND CO.
Product Code: DXY
PMA / PMN Number: P950037
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CAUSE FOR THE TELEMETRY PROBLEMS DESCRIBED IN THE COMPLAINT AFTER A 6.8-YEAR IMPLANTATION PERIOD WAS THE COMPLETELY DEPLETED BATTERY. THE SVC LIFE TIME OF THE PACEMAKER WAS ABOVE THE EXPECTED LIFE TIME. DUE TO THE COMPLETE DISCHARGE OF THE BATTERY AND THUS THE LOSS OF ALL DATA STORED IN THE PACEMAKER, THE ANALYSIS WAS NO LONGER ABLE TO CHECK WHEN ERI HAD BEEN REACHED. FOLLOW-UP DATA TO CONFIRM A COMPLETELY FUNCTIONAL PACEMAKER OUTSIDE THE ERI PERIOD WERE NOT AVAILABLE. THE THOROUGH ANALYSIS OF THE CIRCUIT AND THE BATTERY DO NOT INDICATE A PREMATURE DISCHARGE OF THE BATTERY. THE CIRCUIT SHOWED NO INDICATIONS OF MFG ERRORS OR MATERIAL DEFECTS WHEN EQUIPPED WITH A NEW BATTERY. NO INTERNAL SHORT CIRCUITS OR INTERRUPTIONS, WHICH WOULD ALLOW CONCLUSIONS ABOUT AN ABNORMAL DISCHARGE BEHAVIOR, WERE DETECTED DURING THE COMPREHENSIVE DESTRUCTIVE ANALYSIS OF THE BATTERY BY THE MFR. IN SUMMARY, A NORMAL, COMPLETE BATTERY DISCHARGE WAS FOUND.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PACEMAKER COULD NOT BE INTERROGATED. THE IMPLANTATION PERIOD WAS NOT REPORTED. THE PACEMAKER WAS EXPLANTED. PLEASE NOTE THAT AFTER THE COMPLAINT WAS ISSUED AND THE DEVICE CAME BACK, THE ANALYSIS DEPT WAS ABLE TO OBTAIN IMPLANT AND EXPLANT DATES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	KAIROS DR	PACEMAKER	DXY	BIOTRONIK GMBH AND CO.	121725

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Hospitalization