—#127290

Product

Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8780 Ascenda Intrathecal Catheter.

FDA product code: LKK — Pump, Infusion, Implanted, Programmable
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P860004S125
Affected lot / code info: N457062003

Why it was recalled

Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.

Root cause (FDA determination)

Release of Material/Component prior to receiving test results

Action the firm took

There was only one consignee affected by the recall. The consignee was contacted by phone on 5/2/14 and the information was provided verbally. General Manager & Vice President, Pain Stimulation/Targeted Drug Delivery spoke via phone with the physician managing the patient. The following information was provided: "Medtronic identified the potential for endotoxin levels exceeding USP requirements on product recently implanted (Model 8780, serial number N457062003). "There may be the potential for serious patient injury due to endotoxin within the first hours after implant. "Medtronic recommends observing the patient for symptoms of meningitis. Also to be aware that CSF would not test with a positive culture because endotoxin induced meningitis results in an aseptic meningitis. The physician expressed confidence in the management of the patient and stated he was calling the nursing care facility to increase monitoring of the patient. Subsequent information was received regarding the patient indicating there were no signs of an endotoxin reaction.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: Distributed in the state of CT.

Timeline

Recall initiated: 2014-05-02
Posted by FDA: 2014-06-04
Terminated: 2014-10-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127290. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.