FDA Adverse Event Malfunction Summary report: N

CAPSUREFIX MRI SURESCAN

MDR report key: 3863146 · Received June 10, 2014

Report

Report Number: 2649622-2014-06550
Event Type: Malfunction
Date Received: June 10, 2014
Date of Event: April 29, 2014
Report Date: April 29, 2014
Manufacturer: MPRI
Product Code: NVN
PMA / PMN Number: P090013
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED ATRIAL OVERSENSING. ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) EPISODES RECORDED WITH APPARENT OVERSENSING OF VENTRICULAR PACED AND VENTRICULAR SENSED EVENTS.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5086MRI52 LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

Additional Manufacturer Narrative · 1

CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING OF VENTRICULAR PACE AND/OR VENTRICULAR SENSE EVENTS. THE PATIENT EXPERIENCED THEIR HEART "RACING." THE LEAD REMAINS IN USE AND IS CONTINUED TO BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
340669	CAPSUREFIX MRI SURESCAN	DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE	NVN	MPRI	5086MRI45

Patients

Seq	Age	Sex	Outcome	Treatment
1	00089 YR			RVDR01 IPG