FDA Adverse Event Malfunction Summary report: N

ACUITY

MDR report key: 3905405 · Received July 1, 2014

Report

Report Number: 2124215-2014-11333
Event Type: Malfunction
Date Received: July 1, 2014
Date of Event: January 15, 2014
Report Date: July 31, 2014
Manufacturer: CPI - DEL CARIBE
Product Code: OJX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Additional Manufacturer Narrative · 1

(B)(4). ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS REPROGRAMMED AND REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS LEFT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS THAT HAVE BEEN INCREASED FOR THE PAST FOUR MONTHS. DURING THE VISIT, LEAD MEASUREMENTS WERE WITHIN NORMAL RANGE, HOWEVER WHEN THE PATIENT RAISED THEIR ARMS WHEN STANDING, THE OUT OF RANGE MEASUREMENT WAS OBTAINED. IT WAS THOUGHT THIS LEAD MAY BE FRACTURED. IN THE RING ELECTRODE CONFIGURATION, ACCEPTABLE MEASUREMENTS WERE OBTAINED. THE POLARITY WAS REPROGRAMMED TO TIP-RV AND A FOLLOW UP VISIT WILL BE PERFORMED IN THE NEXT FEW MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

SUBSEQUENTLY, A FOLLOW UP VISIT WAS PERFORMED. INTERROGATION DID NOT REVEAL ANY FURTHER ISSUES. NO CHANGES WERE MADE. IT WAS THOUGHT THE REPROGRAMMING RESOLVED THE ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
383041	ACUITY	IMPLANTABLE LEAD	OJX	CPI - DEL CARIBE	4554

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR			4135\| 4554\| P108\| 0295