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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 Problems Volume Accuracy Problem (1675); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Muscle Spasm(s) (1966); Nausea (1970); Vomiting (2144); Dizziness (2194); Therapeutic Response, Decreased (2271)
Event Date 04/10/2018
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 professional (hcp) regarding a patient who was receiving gablofen, 2000 mcg/ml concentration at 1361 mcg/day dose via intrathecal drug delivery pump for intractable spasticity and cerebral palsy. It was reported that on (b)(6) 2018, the patient had an abrupt onset of nausea, vomiting, dizziness and pruritis with some intermittent spasms. The patient was hospitalized and given po baclofen. The hcp checked the pump logs and no alarms were seen. The hcp stated the dose was increased and the patient's symptoms improved and was discharged from the hospital and the po baclofen was stopped. The hcp stated on (b)(6) 2018 the patient developed again abrupt onset of nausea, vomiting and dizziness. Withdrawal symptom was reported on (b)(6) 2018. No further complications were reported.
 
Manufacturer Narrative
Product id (b)(4) serial# (b)(4) implanted: (b)(4) 2007 explanted: (b)(4) 2018 product type catheter information references the main component of the system. Other relevant device(s) are: product id: (b)(4) , serial #:(b)(4) , ubd: (b)(4) 2008, udi#: (b)(4)update: the previously applied device code (b)(4) is no longer applicable if information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a company representative. On (b)(4) 2018 the physician accessed the pump and found instead of 13 ml, 18 ml. The patient began to have baclofen withdrawal symptoms one week ago. The event occurred during normal use. Diagnostic testing/troubleshooting performed included having accessed the fluid reservoir. It was noted that there were no environmental/external/patient factors that may have led or contributed to the issue. The decision was made at that time to exchange the catheter as well as the pump. The pump and complete catheter were explanted and replaced on (b)(4) 2018. The hcp did not request analysis results. It was noted that the hcp was notified that the product should be returned to the manufacturer; however, the customer refused return / discarded the explanted devices. The issue was resolved at the time of the report. The patient was without injury at the time of the report. It was indicated that the pump administered baclofen with concentration 1000 mcg/ml at a dose rate of 1350. Other medications (oral, etc. ) the patient was receiving at the time of the event was unable to be obtained. The patient¿s weight and medical history was indicated as having been requested but was unknown.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7512050
MDR Text Key108184901
Report Number3004209178-2018-10848
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 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2014
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/14/2013
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: 05/14/2018 Patient Sequence Number: 1
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