PROTECTA XT CRT-D

Report

Report Number: 3004209178-2014-14505
Event Type: Injury
Date Received: August 7, 2014
Date of Event: May 17, 2014
Report Date: May 17, 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: CA, 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. CONCOMITANT MEDICAL PRODUCTS: 4568-53 LEAD, IMPLANTED: (B)(6) 1999; 419688 LEAD, IMPLANTED: (B)(6) 2011. (B)(4). EVALUATION SUMMARY: UPON ANALYSIS, NORMAL BATTERY DEPLETION WAS FOUND.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT RECEIVED FOUR SHOCKS, AND THAT LIA (LEAD INTEGRITY ALERT) TRIGGERED DUE TO SHORT V-V INTERVALS CAUSING ELEVATED SIC (SENSING INTEGRITY COUNTER) AND NST (NON-SUSTAINED TACHYCARDIA) EPISODES. SEVERAL EPISODES OF SLOW VT (VENTRICULAR TACHYCARDIA) WERE NOTED, WHICH WERE EXTERNALLY SHOCKED IN THE EMERGENCY ROOM. THE PHYSICIAN THOUGHT THAT THERE MAY HAVE BEEN SOME FFRW (FAR-FIELD R-WAVE) OVERSENSING AS WELL, AND THAT SIMILAR "NOISE" WAS PRESENT AT THE IMPLANT OF THE DEVICE AT TIME OF INDUCTION. IT WAS ALSO REPORTED THAT THE DEVICE EXPERIENCED REDUCED SERVICE LIFE, DUE TO ELEVATED OUTPUTS AND HIGH PERCENTAGE PACING IN BOTH ATRIUM AND VENTRICLE. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
465097	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	00067 YR		Hospitalization\| R	6942 LEAD