ATTAIN STARFIX

Report

Report Number: 2649622-2010-12936
Event Type: Injury
Date Received: December 13, 2010
Date of Event: September 14, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P060039
Removal / Correction Number: ASKU
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4)THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. FURTHER TESTING REVEALED BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY AND BLOOD IN/ON THE HELIX/LOBE MECHANISM. BLOOD IN THE LOBES WAS OBSERVED. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. FURTHER TESTING REVEALED THAT THE LEAD WAS STRETCHED, AND THE LEAD APPEARED DAMAGED AT IMPLANT.

Description of Event or Problem · 1

IT WAS REPORTED THAT AT IMPLANT, THE RIGHT VENTRICULAR LEAD DISSECTED THE SUPERIOR VENA CAVA DURING THE IMPLANT, AND THE VEIN WAS TOO SMALL TO PASS THE LEAD. THE RIGHT VENTRICULAR LEAD WAS NOT USED AND THE CHRONIC RIGHT VENTRICULAR LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT AT IMPLANT, THREE DIFFERENT LEFT VENTRICULAR LEADS WERE ATTEMPTED BUT ALL CAUSED DIAPHRAGMATIC STIMULATION. THE THREE LEFT VENTRICULAR LEADS WERE NOT USED, AND A DIFFERENT LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ATTAIN STARFIX	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC PUERTO RICO, INC.	4195	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR		Hospitalization\| L\| O\| R	(B)(4)IMPLANTABLE PACING LEAD\| (B)(4) IMPLANTABLE PACING LEAD