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Information was received from a health care professional (hcp) regarding a patient in (b)(6) who received unknown baclofen 500 mcg/ml at a dose of 65.87 mcg/day.It was reported that the patient was transferred to their care due to increased spasticity which started on (b)(6) 2017, also reported as (b)(6) 2017.The day after an unrelated surgery the patient experienced symptoms of abdominal spasticity returning.Spasms and sweating were also reported.The hcp would like to update the pump dose due to the increased spasticity.Despite multiple attempts, they were unable to read the pump.There are no audible pump alarms.The estimated elective replacement indicator (eri) from november was 21 months.Of note, the hcp reported the patient recently had many surgeries which were reported as unrelated to the implanted system and/or therapy but for wound debridement of a different site.The patient had a recent magnetic resonance imaging (mri) scan and x-ray.The reason for the mri was not provided.An x-ray was done a few, three, days ago which indicated the pump orientation was appropriate and did not appear flipped as the identifier could be seen on the image.The catheter/pump connection appeared to be intact.Further troubleshooting during the call included changing batteries, eliminated electromagnetic interference (emi), and additional telemetry attempts which were all unsuccessful.The hcp was going to go and obtain another physician programmer, 8840, from the hospital across the street.The hcp later reported on 2017-feb-10 that two 8840¿s with bbr cards were used and neither would communicate with the pump.Shielding, aluminum foil to further shield the antenna, was also used and communication still was not successful.As reported, the lights were shut off and the user had eliminated emi reporting there were no emi sources present.Again, no alarms could be heard.The caller had been with the patient for 30 minutes and sated the other hospital that transferred the patient did not report hearing any alarms either.Further, the reporter could palpate the fill port and stated in december they read the pump post an mri with no problems.The reason for the mri was not known and a request was made for clarification.The patient had an unrelated surgery in the last month for would debridement of a different site unrelated to the implanted system and/or therapy.Regarding this recent surgery, the hcp stated there was nothing in the op reports indicating any equipment that could cause an issue.The patient was sent back to the hospital from the clinic with oral baclofen 10 mg bid.The hcp stated they would request the representative go back and check the pump again.As reported, they had ruled out radiation, ¿defib, etc.¿.A representative further reported that on (b)(6) 2017 the pump interrogation was attempted again by the representative with yet another 8840 and the interrogation was still unsuccessful as telemetry could not be obtained.The cause of the inability to interrogate the pump was not determined.Of note, the patient was already an inpatient at the initial hospital following his prior surgery, previously reported for wound debridement/issue and unrelated to the implanted system and/or therapy.The patient had been transferred to another facility for the day so the regular care team could investigate the pump.The patient returned to the hospital where the patient was an inpatient at the end of the day.The issue remains unresolved and no potential causes or factors were determined.The representative reported the interrogation findings to the care team and was waiting to hear whether they would plan a replacement.The patient continued with oral baclofen.A hcp reported on 2017-feb-14 that the last refill was (b)(6) 2016 with a dose reported as 65 mcg/day.Further, ¿the day have patient had surgery¿ for a wound in which they were using a debridement product/device on the left trochanter.The pump was more on the right semi-mid-line area of the abdomen.The patient, a ¿large man¿ had also used wound vacs previously.The hcp reported that they planned to attempt to aspirate the pump to see if the volumes were matching which would indicate if the drug was leaving the pump and/or if pump was functional.There continued to be no pump alarms.The hcp indicated that the patient has had six surgeries in december and the patient¿s abdomen was full of stool.Further, on (b)(6) 2017 the representative reported updates from the hcp.They had asked if there were ¿other contributing factors to tone which is where the surgeries presence of wound and stool burden came from¿.The patient has not had ongoing issues with stool burden prior to this that the hcp was aware of and the patient had been using the pump for a number of years.As reported, they did not think the stool issue was pump related.The recent surgery was thought to be (b)(6) and it was for a wound issue; wound debridement.That was the only surgery where they had used this wound device/product according to or record.The volume check had yet to be coordinated as it required transporting patient ¿here¿ for review.This was being coordinated.The patient was unable to leave the hospital bed.The mri, reported as unrelated, was for a review of the spine given the new symptoms of hand pain and tingling.This occurred on (b)(6) 2016 and this did show degenerative changes of cervical stenosis c5-6 with ¿some flattening of cord c6 foramen narrowing¿.This was reported as not pump related.On 2017-feb-16 an hcp further reported that the patient has had five surgeries of grafting and debridement since (b)(6) 2016 with a pressure ulcer/wound located at the left trochanter.The patient also had a couple of heart attacks prior to the wound.The only difference with the surgery on (b)(6) 2017 was a device pump used for the debridement.As previously reported, the next day (b)(6) 2017 the patient complained of increased spasticity.The patient had been on oral baclofen since then.On (b)(6) 2017 the pump reservoir was "easily accessed" with the actual reservoir volume (arv) of 9.5 mls and the expected reservoir volume (erv) of 8.01 mls.This was calculated because they could not establish telemetry with patient¿s pump).The day of surgery, (b)(6) 2017 the erv was 9.34 mls per the reporter who also stated the pump¿s normal error rate was 0.2 mls.They were unsuccessful again on (b)(6) 2017 with obtaining telemetry with the pump and patient was in a different environment/room.They also tried turning off all electrical equipment and utilized a lead apron with being unable to establish telemetry on (b)(6) 2017.They were going to schedule a surgery date to replace the patient¿s pump.
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