FDA Adverse Event Malfunction Summary report: N

TELIGEN

MDR report key: 2905495 · Received January 9, 2013

Report

Report Number: 2124215-2012-14125
Event Type: Malfunction
Date Received: January 9, 2013
Date of Event: July 5, 2011
Report Date: October 11, 2012
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
PMA / PMN Number: P960040
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

Additional Manufacturer Narrative · 1

AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. AN EMAIL WAS SENT TO THE FIELD REPRESENTATIVE IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS BROUGHT INTO THE CLINIC FOR EVALUATION WHERE THE OUT OF RANGE MEASUREMENTS WERE NOT ABLE TO BE REPRODUCED. THE LOGBOOK SHOWED ONE OTHER MEASUREMENT THAT HAD REACHED OUT OF RANGE THREE MONTHS AFTER THE FIRST REGISTERED MEASUREMENT. ALL OTHER DAILY SHOCK IMPEDANCE MEASUREMENTS TREND WITHIN NORMAL LIMITS. SUBSEQUENTLY THE PHYSICIAN HAS OPTED TO MONITOR THE PATIENT. IT WAS NOTED THAT THE PATIENT HAD FALLEN AROUND THE TIME OF THE OUT OF RANGE MEASUREMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
12136	TELIGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	E110

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Required Intervention	E110\| 0180\| 4135