FDA Adverse Event Injury Summary report: N

PROTECTA XT CRT-D

MDR report key: 3991497 · Received August 8, 2014

Report

Report Number: 3004209178-2014-14281
Event Type: Injury
Date Received: August 8, 2014
Date of Event: May 19, 2014
Report Date: May 19, 2014
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: NIK
PMA / PMN Number: P010031
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: DE, 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 DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 694758, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008; 694758, LEAD, IMPLANTED: (B)(6) 2008; 5076-45, LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A LEAD WARNING WAS TRIGGERED FOR HIGH IMPEDANCE ON THE RIGHT VENTRICULAR LEAD. NO NOISE WAS SEEN DURING POCKET MANIPULATION AND ISOMETRICS. A CHEST X-RAY WAS PERFORMED AND THE PHYSICIAN FEELS THAT THE PIN IS IN THE HEADER AND THERE DOES NOT APPEAR TO BE A LEAD BREACH. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ON (B)(6) 2014: DURING THE PROCEDURE TO REPLACE THE RIGHT VENTRICULAR LEAD, THE LEAD TESTED YIELDED "EXCELLENT SENSING, IMPEDANCE, AND THRESHOLD MEASUREMENTS." THE DEVICE WAS REPLACED DUE TO "POTENTIAL DEVICE DEFECT."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
469351	PROTECTA XT CRT-D	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO	NIK	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	D314TRG

Patients

Seq	Age	Sex	Outcome	Treatment
1	00081 YR		Hospitalization\| R	5071-53, LEAD