FDA Adverse Event Malfunction Summary report: N

ACUITY

MDR report key: 2911918 · Received January 11, 2013

Report

Report Number: 2124215-2012-16590
Event Type: Malfunction
Date Received: January 11, 2013
Date of Event: December 7, 2012
Report Date: January 15, 2013
Manufacturer: CPI - DEL CARIBE
Product Code: OJX
PMA / PMN Number: P050046
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE ATTEMPTED LEFT VENTRICULAR LEAD WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL 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.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS LEFT VENTRICULAR LEAD, HIGH PACING IMPEDANCES GREATER THAN 2500 OHMS ALONG WITH UNEXPECTED ATRIAL PACING WAS NOTED. THE LEAD WAS REMOVED AND REPLACED WITH A SECOND LEAD, WHICH SHOWED SIMILAR RESULTS IN THE SAME LEAD POSITION. HOWEVER, ONCE THIS SECOND LEAD WAS REPOSITIONED, NORMAL IMPEDANCE LEVELS AND PACING WERE OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
18266	ACUITY	IMPLANTABLE LEAD	OJX	CPI - DEL CARIBE	4554

Patients

Seq	Age	Sex	Outcome	Treatment
1