Information was received from multiple sources (manufacturer representative (rep), healthcare provider (hcp)) regarding a patient who was receiving gablofen (2000 mcg/ml at 900 mcg/day) via an implantable pump for intractable spasticity.It was reported that the hcp noted that the catheter had sheared.There were no known factors that may have led or contributed to the issue.The hcp added a new 8784, and removed the damaged piece.It was unknown if the issue was resolved at the time of report.The patient's medical history included chest pain.The patient's status at the time of report was alive - no injury.
|
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 18-apr-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
|