FDA Adverse Event Malfunction Summary report: N

ACUITY

MDR report key: 1945659 · Received January 4, 2011

Report

Report Number: 2124215-2010-20090
Event Type: Malfunction
Date Received: January 4, 2011
Date of Event: October 12, 2010
Report Date: April 8, 2011
Manufacturer: CPI - DEL CARIBE
Product Code: OJX
PMA / PMN Number: P050046
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE PHYSICIAN ELECTED TO PROGRAM THE PATIENT'S LV LEAD OFF. NO SURGICAL INTERVENTION WILL BE PERFORMED AT THIS TIME. THE PHYSICIAN PLANS TO EVALUATE THE PATIENT DURING NORMAL FOLLOW-UP. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative · 1

THE COMPLETE LEAD WAS RETURNED. VISUAL OBSERVATIONS NOTED SETSCREW MARKS ON THE TERMINAL PIN AND RING. THE FIXATION WAS IN SPECIFICATION. THE LEAD PASSED ELECTRICAL RESISTANCE TESTING ON ALL PATH. THE ALLEGATION COULD NOT BE CONFIRMED THROUGH ANALYSIS.

Additional Manufacturer Narrative · 1

IT WAS LATER REPORTED THAT THE LEAD WAS EXPLANTED DUE TO AN UNDISCLOSED PATIENT CONDITION. NO FURTHER INFORMATION WAS RECEIVED FROM THE FIELD DESPITE ATTEMPTS.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S TRANSVENOUS LEFT VENTRICULAR (LV) LEAD MAY HAVE DISLODGED SINCE IMPLANT. LV PACING PERCENTAGE MEASUREMENTS HAVE BEEN SIGNIFICANTLY LOWER THAN EXPECTED, AND CONCERN WAS EXPRESSED THAT THE LV LEAD WAS OVERSENSING ATRIAL ACTIVITY. PACING THRESHOLD MEASUREMENTS REMAIN ACCEPTABLE, AND NO X-RAY HAS BEEN OBTAINED TO VERIFY THE LV LEAD POSITION. NO ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THESE OBSERVATIONS. OF NOTE, THE PATIENT IS NOT PACEMAKER DEPENDENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACUITY	IMPLANTABLE LEAD	OJX	CPI - DEL CARIBE	4555

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR			4469\| 0184\| N119\| 4555