K:\My Documents\Cases\Guidant\Court Filings\Complaint ... - BNA

CASE 0:11-cv-00022-DWF -AJB Document 45 Filed 01/27/11 Page 14 of 3551. Guidant opened a tracking report, called a Field Discrepancy Notificationreport (“FDN”), in late February 2002. According to the FDN, Guidant’s lab technicianconcluded that a short between the feedthrough wire and the backfill tube (connected to thedevice case) inside the header was the cause of a high current condition, i.e., arcing. Thearcing depleted the battery, resulting in the inability of the physician to interrogate the deviceand rendering the device unable to deliver a shock if needed. The Guidant technician furthernoted that the insulation of the feedthrough tubing “appear[ed] to have a hole in it[.]”52. In March 2002, another physician reported to Guidant his observation of amalfunctioning implanted Prizm 2. The device was explanted and shipped to Guidant foranalysis.53. In the FDN for this second event, the Guidant lab technician noted that whenthe “[d]evice was charged up to approximately 570 volts, a loud spark and loud snap wasproduced from the header. Visual of the header found the DF negative wire is melted againstthe backfill tube.” The technician concluded that “corrective action is required . . . to ensurethe feedthru wire cannot short against the stem.”54. The arcing in Guidant’s Prizm 2 devices was caused by a breakdown in thepolyimide insulation in a feedthrough wire. When the wire, carrying a negatively chargedcurrent, was positioned too close to the positively charged backfill tube, the current wouldarc from the wire to the tube, causing the device to divert energy away from the leads in ashort circuit, rendering the device ineffective to deliver therapy.55. Guidant itself termed the arcing a “failure mode” for the device.14