FDA Adverse Event Malfunction Summary report: N

ACCENT DR RF

MDR report key: 3830784 · Received May 23, 2014

Report

Report Number: 2017865-2014-03332
Event Type: Malfunction
Date Received: May 23, 2014
Date of Event: September 14, 2011
Manufacturer: ST. JUDE MEDICAL, INC., CRMD
Product Code: DXY
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

Description of Event or Problem · 1

ADDITIONAL INFORMATION (B)(4) 2014 NOTES ANOTHER INSTANCE OF NOISE WITH NOISE REVERSION. NOISE WAS REPRODUCIBLE UPON PRESSING THE PACEMAKER SITE.

Description of Event or Problem · 1

IT WAS REPORTED THE DEVICE EXHIBITED INAPPROPRIATE ATRIAL AMS NOISE. THE DEVICE REMAINS IMPLANTED.

Description of Event or Problem · 1

NEW INFORMATION (B)(4) 2014 NOTES THAT THE DEVICE WAS DETECTING NOISE ONCE AGAIN. THE ATRIAL LEAD IMPEDANCE DROPPED AROUND (B)(4) 2014. THE DEVICE REMAINED IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
307614	ACCENT DR RF	IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY	DXY	ST. JUDE MEDICAL, INC., CRMD	PM2212

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR