SECURA DR

Report

Report Number: 6000094-2011-00230
Event Type: Injury
Date Received: February 15, 2011
Date of Event: October 1, 2010
Manufacturer: MEDTRONIC S.A.
Product Code: LWS
PMA / PMN Number: ASKU
Removal / Correction Number: ASKU
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION.

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE LEAD WAS OVERSENSING AND THE LEAD INTEGRITY ALERT WAS NOT TRIGGERED. IT WAS ALSO REPORTED THAT WHEN THE LEAD WAS CHANGED TO BIPOLAR MODE, THE PATIENT RECEIVED A SHOCK POSSIBLY DUE TO T-WAVE OVERSENSING. THE DEVICE AND LEAD ARE STILL 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
1	SECURA DR	IMPLANTABLE PACEMAKER/CARDIO/DEFIB	LWS	MEDTRONIC S.A.	D234DRG	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| L\| R	5076 IMPLANTABLE PACING LEAD\| 5076 IMPLANTABLE PACING LEAD