Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was receiving baclofen (500 mcg/ml at 99 mcg/day) via an implantable pump.
It was reported that at the scheduled pump refill on (b)(6) 2022, the physician found 18 ml of baclofen in the pump's reservoir while the expected volume was 1.
8 ml.
Regarding diagnostics/troubleshooting performed, it was indicated that reading notes, no abnormal events were reported.
At the last refill on (b)(6) 2022, there was no anomaly during refill.
The patient presented stiffness.
The physician was considering arranging a session to check for possible kinking of the catheter with the contrast medium.
Factors that may have led or contributed to the issue were unknown.
The issue was not resolved as of (b)(6) 2022.
The patient's medical history, gender, age, and weight at the time of the event was unknown or would not be made available.
Additional information was received from a foreign healthcare provider via a company representative on 2022-jun-21.
On (b)(6) 2022 a rotor test showed no abnormalities.
It was further noted that on the other hand, direct access to the catheter revealed a catheter obstruction.
A catheter revision was to be carried out in july.
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Concomitant medical products: product id: 8780, lot#: unknown, product type: catheter.
Other relevant device(s) are: product id: 8780, serial/lot #: unknown.
If information is provided in the future, a supplemental report will be issued.
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