FDA Adverse Event Malfunction Summary report: N

ENERGEN

MDR report key: 3771555 · Received April 24, 2014

Report

Report Number: 2124215-2014-08063
Event Type: Malfunction
Date Received: April 24, 2014
Date of Event: March 24, 2014
Report Date: September 11, 2014
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWP
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

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.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THIS SYSTEM HAD ONGOING ALERT FOR HIGH, OOR, SHOCKING IMPEDANCE MEASUREMENTS OF MORE THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE AND THERE ARE NO PLANS FOR INTERVENTION.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT OF RANGE, SHOCK LEAD IMPEDANCE MEASUREMENT. THE HEALTH CARE PROFESSIONAL (HCP) CALLED TO DETERMINE THE ACTUAL VALUE OF THE PACING LEAD IMPEDANCE MEASUREMENT THAT TRIGGERED THE ALERT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) PROVIDED INFORMATION REGARDING THE ALERT AND SUGGESTED THAT PATIENT CAN DO PATIENT INITIATED INTERROGATION TO DETERMINE THE EXACT VALUE OF THE MEASUREMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT NO INTERVENTION WAS PERFORMED AND THE OUT OF RANGE VALUE WAS CONFIRMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
248688	ENERGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWP	GUIDANT CRM CLONMEL IRELAND	E142

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR			E142\| 4135\| 0292