FDA Adverse Event Malfunction Summary report: N

SECURA DR

MDR report key: 3278197 · Received August 10, 2013

Report

Report Number: 9614453-2013-01925
Event Type: Malfunction
Date Received: August 10, 2013
Date of Event: January 3, 2013
Report Date: June 21, 2013
Manufacturer: IPG MFG SWITZERLAND
Product Code: LWS
PMA / PMN Number: P980016
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THERE WAS AN IMPEDANCE ISSUE ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION CONDUCTOR. ON THE WEEK OF (B)(6) 2014 THE SVC PORT MEASURED 254 OHMS WHERE IT PREVIOUSLY NOTED ¿NONE¿. THE SVC PORT IS PLUGGED.

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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS REGISTERING HIGH IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) COIL WITHOUT AN IMPLANTED SCV COIL PRESENT. THE SCV PORT IS PLUGGED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS LATER REPORTED THAT THE ICD WAS REPROGRAMMED WITH THE SVC TURNED OFF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
381611	SECURA DR	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	IPG MFG SWITZERLAND	D234DRG

Patients

Seq	Age	Sex	Outcome	Treatment
1	00080 YR		Required Intervention