MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dyspnea (1816); Overdose (1988); Pain (1994); Complaint, Ill-Defined (2331)
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Event Date 11/01/2016 |
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, dose 2.75 mg/day) via an implantable pump for spinal pain.Beginning (b)(6) 2016, the patient felt like he was getting too much medication from the pump, patient was having a hard time trying to breathe and he was trying to figure out if he could meet with a company representative to turn the pump down as his health care professional was in a different state.
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Event Description
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Additional information was received from a healthcare provider (hcp) on 2017-jan-11.It was reported that the patient's side effects were noted to have begun on (b)(6) 2016.The patient called the hcp on (b)(6) 2017 and complained of trouble breathing, pain at night, not feeling normal, and overdose symptoms.The hcp recommended going to the emergency room, but the patient declined.It was noted that the patient's pump medication was changed from morphine to dilaudid in either (b)(6) of 2016.The pump was to be checked and the programmed settings were to be verified.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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