FDA Adverse Event Malfunction Summary report: N

DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

MDR report key: 2955257 · Received February 11, 2013

Report

Report Number: 2649622-2013-00811
Event Type: Malfunction
Date Received: February 11, 2013
Report Date: December 3, 2012
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Product Code: LWS
PMA / PMN Number: P920015
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

Additional Manufacturer Narrative · 1

PRODUCT EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE- HIGH RESISTANCE/IMPEDANCE: THERE WERE TWO PATIENT ALERTS FOR OUT OF TOLERANCE (OOT) SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012 02:15:03 AND (B)(6) 2012 02:15:04. WEEKLY AND DAILY PACE LEAD TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MAX RV PACE = 608 TO 21248 OHMD RANGE BETWEEN (B)(6) 2012 AND (B)(6) 2012.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT ALERT TRIGGERED FOR RIGHT VENTRICULAR (RV) LEAD HIGH IMPEDANCE. THEREFORE THE IMPEDANCE UPPER CUT-OFF WAS INCREASED AND THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS ALSO REPORTED THAT THE PATIENT'S IMPLANTED SYSTEM WAS LATER REMOVED DUE TO A HEART TRANSPLANT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
59261		DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA	6944-65

Patients

Seq	Age	Sex	Outcome	Treatment
1	00059 YR			D164VWC IMPLANTABLE PACEMAKER CARDIO/DEFIB