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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 8637-40
Device Problem Excess Flow or Over-Infusion (1311)
Event Date 02/12/2022
Event Type  Injury  
Event Description
Information was received from a friend/family member regarding a patient who was receiving dilaudid (hydromorphone) (concentration and dose unknown) via an implantable pump for spinal pain. It was reported that a week ago, the patient "started feeling funny". It was noted "not last night but the night before, she felt like it started pushing drugs into her". The patient got a sharp pain in their belly and it felt like someone was "iv piercing" their stomach. The patient became loopy from the drugs and started having seizures. The patient was taken byambulance to the emergency room (er) but sent home. It was further reported they took the patient to another hospital where their blood pressure (bp) was 88/64 and the patient was having seizures in the waiting room, and the hospital staff told caller they could not help them and sent them to another hospital. They went to another hospital where the patient had two seizures in the waiting room, then would not allow the caller back with the patient due to covid. The patient reported they were rude, ignored them, and "didn't care if she lived or died". The patient continued to complain of sharp pain in the belly at the pump area and was not sure if it was the drugs going to their head or if it was truly painful.   the caller was asking for help finding someone to check the patent's pump as the patient "almost died twice of overdose" and they could not find anyone to help. They called the patient's healthcare provider (hcp) who told the caller "she would be dead by the time you got here".
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key13770231
MDR Text Key287260314
Report Number3004209178-2022-03299
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
Reporter Occupation Non-Healthcare Professional
Report Date 03/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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