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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 Fluid Leak (1250)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Memory Loss/Impairment (1958); Cognitive Changes (2551)
Event Date 08/23/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2021, information was received from a patient receiving dilaudid via an implantable pump for non-malignant pain. It was reported that about 3 weeks ago, the patient was hallucinating and "saying things to people that i don't remember" and had a fall. The patient stated that in the fall, they broke their wrist and was put in a cast. The patient stated the pain from their wrist was "almost as bad as my spine at an 8". The patient stated that when they were hospitalized due to hallucinations and fall, "the doctor there and nurses all said the pain pump had leached which was the reason for my hallucinations and all the other wacky stuff i was doing , and they said i had it shut off". The patient also stated that in their hospital paperwork, they wrote that the patient went through withdrawal. The patient stated they were supposed to have a refill on (b)(6) 2021. The doctor, "had it running at 600 or 6,000. Six something. " the patient stated the doctor told them they had enough medication and rescheduled the patient to (b)(6) 2021 for a refill and the patient had to have another psychological approval before the doctor would fill the pump again. The patient stated they were told by their pain management healthcare professional (hcp), the pump was never shut off in the first place as hospital staff said. The patient stated they were afraid to have the pump refilled because they were "afraid it's going to leak again" and they didn't want to go through that again. The patient was redirected to their hcp for further assistance.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12547367
MDR Text Key273799070
Report Number3004209178-2021-14570
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2021
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/09/2020
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: 09/29/2021 Patient Sequence Number: 1
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