FDA Adverse Event Injury Summary report: N

PROTECTA CRT-D

MDR report key: 3992032 · Received August 8, 2014

Report

Report Number: 9614453-2014-02002
Event Type: Injury
Date Received: August 8, 2014
Date of Event: March 19, 2014
Report Date: March 19, 2014
Manufacturer: IPG MFG SWITZERLAND
Product Code: NIK
PMA / PMN Number: P010031
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY : THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED ELECTROMAGNETIC INTERFERENCE (EMI) NOISE ON BOTH THE ATRIAL AND VENTRICULAR CHANNELS WITH INAPPROPRIATE SHOCK.

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 EXPERIENCED INAPPROPRIATE THERAPY DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) CAUSING EPISODES OF NOISE THAT MET THE VENTRICULAR FIBRILLATION (VF) DETECTION CRITERIA. THE DEVICE ELECTROGRAM (EGM) SHOWS CONTINUED EMI, AND TROUBLE-SHOOTING IS ONGOING TO DETERMINE WHAT THE PATIENT WAS DOING AT THE TIME IN ORDER TO IDENTIFY THE EXTERNAL SOURCE. THE DEVICE REMAINS 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
470762	PROTECTA CRT-D	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO	NIK	IPG MFG SWITZERLAND	D364TRG

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| L\| R