FDA Adverse Event Malfunction Summary report: N

VIVA QUAD S

MDR report key: 3992307 · Received August 8, 2014

Report

Report Number: 3004209178-2014-14865
Event Type: Malfunction
Date Received: August 8, 2014
Date of Event: June 27, 2014
Report Date: June 30, 2014
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: NIK
PMA / PMN Number: P010031
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE, AND THERE WAS A LEAD IMPEDANCE OUT OF RANGE ALERT.

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 MEDICAL PRODUCTS: 419588 LEAD, IMPLANTED: (B)(6) 2014; 5076-52 LEAD, IMPLANTED: (B)(6) 2014. (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 THE PATIENT PRESENTED DUE TO HEARING TONES FOLLOWING AN RF (RADIO FREQUENCY) ABLATION PROCEDURE. AN ALERT FOR HIGH RV (RIGHT VENTRICULAR) PACING IMPEDANCE WAS NOTED, WHICH TRIGGERED AT THE SAME TIME AS THE PROCEDURE. ALL IMPEDANCES WERE STABLE AND NORMAL WHEN CHECKED LATER, EVEN WITH PROVOCATIVE TESTING. THE DEVICE REMAINS 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
471989	VIVA QUAD S	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO	NIK	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	DTBB1D4

Patients

Seq	Age	Sex	Outcome	Treatment
1	00084 YR			6947M62 LEAD