KAPPA 900 DR

MDR report key: 3993037 · Received August 8, 2014

Report

Report Number: 9614453-2014-01928
Event Type: Malfunction
Date Received: August 8, 2014
Date of Event: June 11, 2014
Report Date: June 11, 2014
Manufacturer: IPG MFG SWITZERLAND
Product Code: DXY
PMA / PMN Number: P980035
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. CONCOMITANT: 5554-53 LEAD IMPLANTED: 2000-(B)(6). (B)(4).

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS SUSPECTED PACING FAILURE OR OVERSENSING. THE DEVICE AND LEADS WERE CHECKED AND NO PROBLEM FOUND. HOLTER MONITORING WAS PERFORMED, WITH NO PACING FAILURE NOTED. IT WAS THEN SUSPECTED THAT THE PREVIOUSLY REPORTED PACING FAILURE MIGHT HAVE BEEN CAUSED BY INSUFFICIENT OUTPUT IN RELATION TO THE THRESHOLD, AS A RESULT OF DAILY VARIATION TRIGGERED BY THE ADJUSTMENT OF THE VCM (VENTRICULAR CAPTURE MANAGEMENT) LOWER LIMIT. THE DEVICE AND RV (RIGHT VENTRICULAR) LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
472731	KAPPA 900 DR	PULSE-GENERATOR, PACEMAKER, IMPLANTABLE	DXY	IPG MFG SWITZERLAND	KDR931J

Patients

Seq	Age	Sex	Outcome	Treatment
1	00083 YR			5054-58 LEAD