FDA Adverse Event Injury Summary report: N

VIVA QUAD XT

MDR report key: 5281895 · Received December 9, 2015

Report

Report Number: 2182208-2015-04388
Event Type: Injury
Date Received: December 9, 2015
Date of Event: January 1, 2015
Report Date: October 22, 2015
Manufacturer: MEDTRONIC, INC.
Product Code: DXY
PMA / PMN Number: P010031
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: A BATTERY LIFE BEYOND HIS "EXPECTANCY". PACE PACING AND CLINICAL ELECTROPHYSIOLOGY. 2015;38(10):1228-1230. (B)(4).

Description of Event or Problem · 1

A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ARTICLE INDICATED THAT INTERROGATION OF THE DEVICE SHOWED A POWER-ON-RESET. THE LONGEVITY OF THE BATTERY SHOWED LESS THAN ONE MONTH; WHILE THE BATTERY VOLTAGE WAS WITHIN NORMAL RANGE. THE ARTICLE STATED THAT THERE WAS NO PLAUSIBLE CAUSE FOR THIS. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
811695	VIVA QUAD XT	PULSE-GENERATOR, PACEMAKER, IMPLANTABLE	DXY	MEDTRONIC, INC.	MDT-ICD

Patients

Seq	Age	Sex	Outcome	Treatment
1	00077 YR		Required Intervention	IMPLANTABLE TACHY LEAD