FDA Adverse Event Malfunction Summary report: N

EXCELLENCE+

MDR report key: 4831561 · Received June 10, 2015

Report

Report Number: 2649622-2015-05501
Event Type: Malfunction
Date Received: June 10, 2015
Date of Event: January 1, 2015
Report Date: March 31, 2015
Manufacturer: MPRI
Product Code: DTB
PMA / PMN Number: P830061
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS; HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED ATRIAL OVERSENSING, THE ANALYST NOTED: ATRIAL HIGH RATE EPISODES WERE RECORDED ON (B)(6) 2015 WITH APPARENT OVERSENSING SEEN ON THE EGMS. HIGH COUNT OF LOW IMPEDANCE / SHORT CIRCUIT PACES. ATRIAL LEAD WARNING OCCURRED ON (B)(6) 2013. CHRONIC TREND DATA SHOWS AVERAGE ATRIAL IMPEDANCE STEADY AT APPROXIMATELY 225 OHMS WITH A LIFETIME MINIMUM MEASUREMENT OF 179 OHMS. CONCOMITANT MEDICAL PRODUCTS: ADDRL1, IPG, IMPLANTED: (B)(6) 2008 (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD HAD NOISE. DIAGNOSTIC TESTING WAS PERFORMED AND THE LEAD SETTINGS WERE STABLE. THE PERFORMANCE OF THE LEADS WILL CONTINUE TO BE MONITORED AND BOTH 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
378486	EXCELLENCE+	ELECTRODE, PACEMAKER, PERMANENT	DTB	MPRI	IMD49JB45	VLG006510V

Patients

Seq	Age	Sex	Outcome	Treatment
1	00068 YR			402352V LEAD