FDA Adverse Event Injury Summary report: N

PHILOS II DR-T

MDR report key: 3891466 · Received June 24, 2014

Report

Report Number: 1028232-2014-002081
Event Type: Injury
Date Received: June 24, 2014
Date of Event: May 12, 2014
Report Date: June 11, 2014
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: DXY
PMA / PMN Number: P950037
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ANALYSIS IS THUS BASED ON THE EXISTING PRODUCTION DOCUMENTS AND THE DEVICE DATA SUBMITTED. THE SUBMITTED DEVICE DATA WERE ANALYZED EXTENSIVELY, IN PARTICULAR THE IEGM RECORDED ON (B)(6) 2014. THIS DOCUMENTED THAT AN INEFFECTIVE SAFETY STIMULUS WAS DELIVERED DUE TO A VENTRICULAR SENSE EVENT AND AS A RESULT BACKUP STIMULUS WAS DELIVERED. AFTER THIS CHAIN OF EVENTS, VENTRICULAR TACHYCARDIA WAS RECORDED IN THE IEGM. THE CAUSE OF THE INITIAL SIGNAL AND ALSO THE TACHYCARDIA CANNOT BE DETERMINED BASED ON THE AVAILABLE DATA. THE PRODUCTION PROCESS FOR THIS DEVICE WAS CHECKED. THE PRODUCTION DOCUMENTS DO NOT SHOW ANY IRREGULARITIES THAT COULD BE RELATED TO THE INCIDENT. ALL PRODUCTION STEPS WERE CORRECTLY EXECUTED. IN SUMMARY, THERE IS NO INDICATION OF A PRODUCTION DEFECT. THE CLINICAL OBSERVATION COULD BE CONFIRMED. HOWEVER, BASED ON THE DEVICE DATA AVAILABLE, THE UNDERLYING CAUSE OF THE CLINICAL OBSERVATION COULD NOT BE DETERMINED. THERE WAS NO INDICATION OF THE DEVICE MALFUNCTIONING.

Description of Event or Problem · 1

OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 47 MONTHS, SYNCOPE FOR THIS FEMALE PATIENT WAS REPORTED. SYNCOPE ASIDE, NO FURTHER WORSENING IN THE PATIENT'S HEALTH WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
369026	PHILOS II DR-T	PACEMAKER	DXY	BIOTRONIK SE & CO. KG	343175

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other