Table 3.

Product Performance Events Vs Non-Product Performance Events

Product Performance Events	Non-Product Performance Events
Catheter kink/occlusion	Pharmacologic: Acute (Nausea, urinary retention, pruritis, respiratory depression), chronic (persistent for at least 4 weeks, due to opioid, ziconotide or bupivacaine side effects)
Catheter dislodgment from the intrathecal space	Procedural: minor infections (superficial wound infections, painful wound fibrosis), serious infections (meningitis, wound pocket infection with clinical signs and/or symptoms for sepsis)
Catheter breakage	Procedural: persistent spinal headache
Motor stall	CSF leakage at the catheter and pump connection site with a small seroma
Catheter related complication (malfunction, difficulty in aspiration, torsion preventing side port aspiration, sediment, compression, etc.)	Granuloma
Medical device complication (pump connector breakage, pump malfunction, catheter anchor breakage, pump unable to interrogate or program, inability to aspirate CSF, overinfusion, alarms, etc.)	Psychological category: distorted body image
Reduced battery performance
Deformed pump tube
Motor malfunction