SPRINT QUATTRO SECURE S

Report

Report Number: 2649622-2010-14131
Event Type: Malfunction
Date Received: December 14, 2010
Date of Event: October 5, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: LWS
PMA / PMN Number: P920015/S039
Removal / Correction Number: ASKU
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FS
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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THE HELIX WAS DISENGAGED FROM THE HELICAL CHANNEL. BLOOD WAS PRESENT IN/ON THE HELIX MECHANISM. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, IT WAS "IMPOSSIBLE TO OPEN THE SCREW." THE LEAD WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPRINT QUATTRO SECURE S	IMPLANTABLE TACHY LEAD	LWS	MEDTRONIC PUERTO RICO, INC.	6935	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other