FDA Adverse Event Injury Summary report: N

EASYTRAK 2

MDR report key: 2945334 · Received February 6, 2013

Report

Report Number: 2124215-2013-02573
Event Type: Injury
Date Received: February 6, 2013
Date of Event: November 2, 2012
Report Date: November 2, 2012
Manufacturer: CPI - DEL CARIBE
Product Code: OJX
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF THE COILS BEING EXTREMELY STRETCHED AT THE TIP REGION OF THE LEAD WHERE THE ELECTRODE TIP UNIT FRACTURED OFF. THE ELECTRODE TIP WAS MISSING AND WAS NOT RETURNED. ANALYSIS CONCLUDED THAT THE DAMAGE WAS LIKELY INDUCED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS UNABLE TO BE IMPLANTED. DURING THE IMPLANT PROCEDURE, THE LEAD WAS PUT INTO A SMALL TARGET VEIN; HOWEVER, THE PHYSICIAN WAS UNABLE TO GET THE LEAD FAR ENOUGH INTO THE VESSEL. WHILE PULLING OUT THE LEAD, THE TIP OF THE LEAD BROKE OFF. THE LEAD TIP STAYED IN THE TARGET VEIN AND THE PHYSICIAN DECIDED TO LEAVE IT THERE AS HE FELT IT WAS NOT GOING TO MOVE. IT WAS NOTED THAT THE LEAD DID NOT APPEAR TO MOVE AT ALL AFTER TESTING. AFTER THE IMPLANT PROCEDURE, ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS AND NO ISSUES WERE REPORTED. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. A TECHNICAL SERVICE (TS) CONSULTANT WAS CONTACTED REGARDING THIS ISSUE AND DISCUSSED OBTAINING AN X-RAY IN THE FUTURE TO DETERMINE IF THE LEAD WAS STILL IN THE VEIN. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
51091	EASYTRAK 2	IMPLANTABLE LEAD	OJX	CPI - DEL CARIBE	4543

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| L\| R