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U.S. Department of Health and Human Services

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

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MDT 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)
Patient Problems Encephalopathy (1833); Vomiting (2144); Dysphasia (2195); Ambulation Difficulties (2544); Cognitive Changes (2551)
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving unknown drug via an implanted pump. It was reported the patient went to the er in (b)(6) 2019, two days after getting a refill with symptoms of overdose (altered mental state, couldn t walk, slurred speech, vomiting, etc. ). It was noted there was a possible pocket fill. The patient stayed in the hospital for at least 8 days. The patient alleged the pump was malfunctioning, and the doctor suspected, especially because family said during refill doc noted pump had gone through more that it should have. The hcp noted the acute toxic encephalopathy could be due to narcotics from the pain pump. However, no one found a leak or anything wrong with pump. The hcp interrogated the pump and it was fine. Patient returned to baseline and they replaced the pump, presumably as a precaution.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13585750
MDR Text Key286044153
Report Number3004209178-2022-02411
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 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2014
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/28/2012
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: 02/23/2022 Patient Sequence Number: 1
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