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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 Insufficient Information (3190)
Patient Problems Low Blood Pressure/ Hypotension (1914); Overdose (1988); Decreased Respiratory Rate (2485); Cognitive Changes (2551)
Event Date 01/30/2020
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 healthcare provider via a company representative regarding a patient receiving lioresal 2000mcg/ml at 300cmg/day via an implantable pump. The indications for use were intractable spasticity and cerebral palsy. On (b)(6) 2020 it was reported that the patient reported to the er (emergency room) on (b)(6) 2020 with altered mental status, hypotension, and respiratory depression which required intubation. The patient was thought to have signs and symptoms itb (intrathecal baclofen) overdose. Per report, the patient was transferred to the neuro icu (intensive care unit). Per report there were no factors that contributed to the event. No troubleshooting was performed but an x-ray was completed showing the catheter intact. The actions and interventions taken to resolve the issue was it was suspected that the patient had a pump and or catheter issue, so the physician took the patient to or (operating room) today, (b)(6) 2020 to replace the pump and explore the potential catheter issue. Per the physician, there was no catheter issue found as the catheter was patent and he was able to withdraw 2cc from catheter access port, so the decision to just replace the pump was made. The issue was resolved at the time of the report and it was noted that the healthcare provider would have no further information regarding the event. The patient status was noted as alive, no injury and no further complications were reported or anticipated.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key9659722
MDR Text Key185548527
Report Number3004209178-2020-02385
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2014
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2013
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: 02/03/2020 Patient Sequence Number: 1
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