FDA Adverse Event Injury Summary report: N

ACUITY

MDR report key: 2407053 · Received January 10, 2012

Report

Report Number: 2124215-2011-19141
Event Type: Injury
Date Received: January 10, 2012
Date of Event: November 8, 2011
Report Date: July 27, 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, THIS LEAD WILL BE ANALYZED AND THIS INVESTIGATION WILL BE UPDATED.

Additional Manufacturer Narrative · 1

UPON RETURN, THIS LEAD WAS THOROUGHLY ANALYZED. VISUAL EXAMINATION REVEALED DRIED BLOOD WITHIN THE LEAD LUMEN AND SURFACE ABRASIONS AT 872-875 MM FROM THE TERMINAL PIN. EXTENSIVE TESTING WAS PERFORMED TO ASSESS THE LEAD'S ELECTRICAL INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS DEMONSTRATED CONTINUITY OF THE ELECTRICAL CIRCUITRY. RIGOROUS TESTING, INCLUDING EXTENSIVE LEAD MANIPULATION WHILE CONNECTED TO AN OHMMETER, VERIFIED THERE WERE NO INTERMITTENCIES IN THE ELECTRICAL CONDUCTIVITY. ANALYSIS CONCLUDED THAT THE LEAD WAS ELECTRICALLY CONTINUOUS, WITH ENGINEERS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATION OF CAPTURE LOSS; HOWEVER, INSULATION ANOMALIES WERE OBSERVED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT THIS LEFT VENTRICULAR (LV) LEAD HAD LOSS OF CAPTURE EVEN WITH MAXIMUM OUTPUTS. AN X-RAY REVEALED THAT THIS LV LEAD HAD DISLODGED. A REVISION PROCEDURE WAS PERFORMED TO EXPLANT AND REPLACE THIS LEAD. UPON EXPLANT, IT WAS NOTICED THAT THIS LV LEAD HAD INSULATION DAMAGE. THIS LEAD WILL BE RETURNED FOR ANALYSIS. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACUITY	IMPLANTABLE HF LEAD	OJX	CPI - DEL CARIBE	4592

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R