Concomitant medical products: product id 8780, lot# serial# (b)(4), implanted: (b)(6) 2018, product type: catheter.
Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 22-aug-2015, udi#: (b)(4).
If information is provided in the future, a supplemental report will be issued.
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Information was received from a company representative (rep) via a healthcare provider (hcp) regarding a patient with an implantable infusion pump receiving baclofen (loiresal) with a concentration of 2000 mcg/ml and a dose of 800 mcg/day for intractable spasticity and head/brain injury.
It was mentioned hcp stated patient had spinal surgery last week and the patient had tachycardia, agitation and hypertension post surgery.
Hcp stated the patient has been hospitalized since the surgery.
Hcp stated on friday of last week they did a cap aspiration to check the catheter and were able to aspirate freely from the cap and re-primed the tcv.
Hcp stated patient had some hypotension post aspiration and since he has had a fever, hypotension and hypertension.
Hcp stated today they attempted a cap dye study and were only able to aspirate 0.
8ml of fluid.
Hcp was wondering about re-priming now.
Hcp stated they are going to rule out infection also.
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