MalfunctionNHW

PATCH

Received Jan 22, 2013 · Event occurred Nov 21, 2012

Report 2124215-2013-01617 · MDR key 2924952

Device

Generic name

Implantable Lead

Manufacturer

Cpi - Del Caribe

Model number

0067

Product problems

High impedance

Patient

66 YR

No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE DAILY MEASUREMENTS SHOW IMPEDANCE AT 60-80 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED TROUBLESHOOTING OPTIONS. A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TEST WAS SCHEDULED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

Additional Manufacturer Narrative

ALL AVAILABLE INFORMATION INDICATES THE DEVICE REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.