MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Material Integrity Problem (2978)
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Patient Problems
Dehydration (1807); High Blood Pressure/ Hypertension (1908); Vomiting (2144); Insufficient Information (4580)
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Event Type
Injury
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Event Description
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Information was received from a patient who was receiving dilaudid (unknown concentration or dose) via an implantable pump for unknown indications for use.It was reported that the patient's pain pump malfunctioned "about 2 months ago.I guess the catheter broke and having horrible withdrawals".The patient stated that they did a catheter dye study about 1 month ago and it was still not taken cared of.When asked dose and concentration of the dilaudid, the patient stated, "i think it was 0.2or at least it had a 2 in it".The patient stated, "i have missed 2 months of work" and noted that they just got out of intensive care the night before last ((b)(6) 2022) due to not getting medication. the patient noted that their physician did not give them anything to help with the withdrawals.The patient stated being severely dehydrated, vitamin deficiency, and extremely high blood pressure."i can barely keep anything down and the doctor doesn't seem to be in a hurry to help me".The patient was redirected to their healthcare provider to further address the issue.
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Manufacturer Narrative
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Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 26-sep-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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