FDA Adverse Event Malfunction Summary report: N

PUNCTUA

MDR report key: 3921733 · Received July 9, 2014

Report

Report Number: 2124215-2014-11699
Event Type: Malfunction
Date Received: July 9, 2014
Date of Event: May 1, 2014
Report Date: May 2, 2014
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWP
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT OF RANGE SHOCKING LEAD IMPEDANCE MEASUREMENT DETECTED VIA THE PATIENT REMOTE MONITORING SYSTEM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED DAILY MEASUREMENTS AND INDICATED THAT TREND SEEMED STABLE BUT NOTED A SLIGHT INCREASE IN IMPEDANCE. FURTHERMORE, TS DISCUSSED FACTORS THAT MAY CAUSE OUT OF RANGE IMPEDANCE AND PROVIDED TROUBLESHOOTING OPTIONS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS SEEN FOR FURTHER EVALUATION AND NORMAL FINDINGS WERE OBSERVED. THE PATIENT WILL BE MONITORED CONTINUOUSLY. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
400131	PUNCTUA	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWP	GUIDANT CRM CLONMEL IRELAND	N051

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR			N051\| MISMATCH\| 4555\| T135\| 5076\| 0158\| E102