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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Granuloma (1876); Nausea (1970); Pain (1994); Vomiting (2144); Dysphasia (2195); Malaise (2359); Ambulation Difficulties (2544); Cognitive Changes (2551)
Event Date 07/15/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2021, product type: catheter. Information references the main component of the system. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 22-jun-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was receiving morphine (unknown) (asked unknown mg/ml at asked unknown mg/day) via an im plantable pump for non-malignant pain. It was reported that since implant the patient had been nauseous, sick, vomiting, keeps falling, had fallen 7x and had a scab on his left knee cap. He falls down the steps of the house and when he walks down the hall he has to hold himself up with his arms. It was noted the patient was unable to walk, think, talk, carry on a conversation and has increased pain. The patient could smell and tastes the medication and it burned his nose and tastes awful. The patient to do a nasal wash 3-4 times a day and continued to blow unbelievable stuff out of his nose. The patient thought he has a granuloma because when the doctor fills the pump the patient's pain goes shooting and he could not even think. It was noted due to the patient's vomiting the doctor put some sort of anti-medic into the pump but he did not know what medication. When asked dose and concentration of the medication, it was reported it was up to 2. 5-2. 6 mg per day "or something like that" but the patient continued to have symptoms. The doctor reduced the pump and it was making her throw up then the doctor decreased meds to 40%, the patient went through withdrawals and after that he was going ok but was still smelling and tasting the medication all the time. The patient continued telling the doctor he did not want morphine in the pump he wants dilaudid. It was noted the pump was running out and the doctor put in diluted morphine and told the patient he would be fine which the patient was not. The doctor told him he did not have dilaudid and needed to fill the pump with morphine because that was all he had, so the doctor diluted it. The patient wanted to have dilaudid in the pump to try that or he wanted to have the pump removed. The patient was redirected to their healthcare provider to further address the issue. Additional information was received from a healthcare provider (hcp) on 2022-jan-20 indicated a catheter granuloma was not confirmed, however an mri has been ordered. Regarding the patient¿s symptoms, it was noted the dose of the intrathecal morphine had been reduced and the plan was to discuss the prescription. Diagnostics/troubleshooting performed included, the patient reported, ¿illegible¿. No hourly ¿illegible¿. For now, the hcp was reducing the intrathecal dose of morphine and bupivacaine. It was noted the patient has had multiple surgical procedures and all failed to relieve his pain. Actions/interventions included progressive reduction of intrathecal morphine and a spinal tap. It was noted at this stage, the hcp was not happy, and patient has a ¿illegible¿. The hcp¿s plan was to completely stop the prescription in the pump.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13537931
MDR Text Key286882483
Report Number3004209178-2022-02082
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/15/2022 Patient Sequence Number: 1
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