FDA Adverse Event Injury Summary report: N

ENDOTAK RELIANCE

MDR report key: 1945655 · Received January 4, 2011

Report

Report Number: 2124215-2010-20216
Event Type: Injury
Date Received: January 4, 2011
Date of Event: October 8, 2010
Report Date: November 15, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, A VISUAL INSPECTION REVEALED THE HELIX WAS RETRACTED AND BLOOD/BODY FLUID WAS NOTED IN THE HELIX MECHANISM. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES. ANALYSIS COULD NOT DETERMINE A REASON FOR THE REPORTED CLINICAL ALLEGATION.

Additional Manufacturer Narrative · 1

ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WILL BE RETURNED FOR ANALYSIS. UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, THIS LEAD WILL UNDERGO ANALYSIS AND THIS EVENT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR LEAD WAS IMPLANTED. DESPITE SEVERAL ATTEMPTS TO REPOSITION THIS LEAD, WHEN CONNECTED TO THE PACING SYSTEM ANALYZER, HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS WERE OBTAINED. THE LEAD WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOTAK RELIANCE		NVY	CPI - DEL CARIBE	0295

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention