FDA Adverse Event Injury Summary report: N

CONSULTA CRT-P

MDR report key: 2965118 · Received February 15, 2013

Report

Report Number: 9614453-2013-00333
Event Type: Injury
Date Received: February 15, 2013
Date of Event: June 6, 2012
Report Date: February 13, 2013
Manufacturer: IPG MFG SWITZERLAND
Product Code: NVZ
PMA / PMN Number: P010015
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE U.S., HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. COMPETITOR IMPLANTABLE PACING LEAD: (B)(4), IMPLANTED: (B)(6) 2001. (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. THERE WERE NO ANOMALIES FOUND.

Description of Event or Problem · 1

IT WAS REPORTED THAT IMPLANT DETECT ON THE IMPLANTABLE PULSE GENERATOR (IPG) DID NOT COMPLETE DUE TO NO ATRIAL LEAD IMPLANTED RELATED TO THE PATIENT HAVING ATRIAL FIBRILLATION. BECAUSE OF THE MISSING ATRIAL LEAD, IMPLANT DETECTION DID NOT AUTOMATICALLY COMPLETE AND DIAGNOSTICS AND OTHER FEATURES CANNOT WORK AS DESIGNED. THE DEVICE WAS REPROGRAMMED TO "IMPLANT DETECT" OFF AND IS STILL 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
68518	CONSULTA CRT-P	PULSE GENERATOR, PERMANENT, IMPLANTABLE	NVZ	IPG MFG SWITZERLAND	C3TR01

Patients

Seq	Age	Sex	Outcome	Treatment
1	00069 YR		Required Intervention	5076 IMPLANTABLE PACING LEAD